Merit Medical® · Initial Release
Merit Medical Systems, Inc.
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Public device record key
- b100b285-3b5c-4297-a7cb-2b7f0d134068
- Has serial number
- false
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 1
- Labeler duns number
- 603160040
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- Initial Release
- Has manufacturing date
- false
- Brand name
- Merit Medical®
- Is combination product
- false
- Is kit
- true
- Device count in base package
- 1
- Is pm exempt
- true
- Has lot or batch number
- true
- Catalog number
- K12T-12593A
- Company name
- Merit Medical Systems, Inc.
- Public version status
- New
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2026-07-24
- Sterilization
- Is sterile
- true
- Is sterilization prior use
- false
- Identifiers
- ID
- 00884450486214
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- OEQ
- Name
- Angiography/angioplasty kit
- Harmonized identifiers (openFDA)
- Device name
- Angiography/Angioplasty Kit
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1650
- Device class
- 2
- Gmdn terms
- Code
- 33961
- Name
- General surgical procedure kit, non-medicated, single-use
- Implantable
- false
- Code status
- Active
- Definition
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.