Regulations research / FDA data / Establishments and listings / Laparoscope General and Plastic Surgery - DeRoyal Establishments and listings Laparoscope General and Plastic Surgery - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 1043214 GCJ
K number K171475
Proprietary name Laparoscope General and Plastic Surgery - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code GCJ
Created date 2019-06-06
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Laparoscope, General & Plastic Surgery
Medical specialty description Gastroenterology, Urology
Regulation number 876.1500
Device class 2 Establishments and listings Cannula, surgical, General & Plastic Surgery - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1043214 GEA
K number K982472
Proprietary name Cannula, surgical, General & Plastic Surgery - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code GEA
Created date 2012-10-24
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Cannula, Surgical, General & Plastic Surgery
Medical specialty description General, Plastic Surgery
Regulation number 878.4800
Device class 1 Establishments and listings Cannula Vial Access - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1043214 FGY
Proprietary name Cannula Vial Access - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code FGY
Created date 2016-03-07
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Cannula, Injection
Medical specialty description General, Plastic Surgery
Regulation number 878.4200
Device class 1 Establishments and listings Syringe, Piston - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1043214 FMF
K number K980987
Proprietary name Syringe, Piston - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code FMF
Created date 2016-01-14
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Syringe, Piston
Medical specialty description General Hospital
Regulation number 880.5860
Device class 2 Establishments and listings Crutch - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1043214 IPR
Proprietary name Crutch - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code IPR
Created date 2010-03-18
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Crutch
Medical specialty description Physical Medicine
Regulation number 890.3150
Device class 1 Establishments and listings Nerve Block Tray (Kit) - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 1043214 OGJ
Proprietary name Nerve Block Tray (Kit) - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code OGJ
Created date 2016-05-17
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Nerve Block Tray
Medical specialty description Anesthesiology
Regulation number 868.5140
Device class 2 Establishments and listings Yankauer - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Develop Specifications But Do Not Manufacture At This Facility +1 Reg. 1043214 GCX
Proprietary name Yankauer - DeRoyal
Establishment type Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code GCX
Created date 2003-04-04
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Medical specialty description General Hospital
Regulation number 880.6740
Device class 2 Establishments and listings Cannula, Manipulator/Injector, Uterine - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1043214 LKF
K number K092980
Proprietary name Cannula, Manipulator/Injector, Uterine - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code LKF
Created date 2024-12-13
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Cannula, Manipulator/Injector, Uterine
Medical specialty description Obstetrics/Gynecology
Regulation number 884.4530
Device class 2 Establishments and listings Cotton, Roll - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Develop Specifications But Do Not Manufacture At This Facility +1 Reg. 1043214 EFN
Proprietary name Cotton, Roll - DeRoyal
Establishment type Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code EFN
Created date 2004-10-15
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Cotton, Roll
Medical specialty description Dental
Regulation number 872.6050
Device class 1 Establishments and listings Syringe Piston - DeRoyal DEROYAL INDUSTRIES, INC. · POWELL, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1043214 FMF
K number K962042
Proprietary name Syringe Piston - DeRoyal
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1043214
FEI number 1043214
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DEROYAL INDUSTRIES, INC.
Address line 1 200 DEBUSK LN.
City POWELL
State code TN
Iso country code US
Zip code 37849 Owner operator
Firm name DEROYAL INDUSTRIES, INC.
Owner operator number 1044833 Official correspondent
First name Elizabeth
Last name Reed
Phone number x-865-3621256-x Contact address
Address 1 200 DEBUSK LN.
Address 2 --
City Powell
State code TN
Iso country code US
Postal code 37849 Products
Product code FMF
Created date 2016-01-14
Owner operator number 1044833 Harmonized identifiers (openFDA)
Device name Syringe, Piston
Medical specialty description General Hospital
Regulation number 880.5860
Device class 2 588 records share this identifier (an establishment lists each device separately); the first 10 are shown.
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Data from openFDA , FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.