FLOWTUBE HF · 1299-10-15
Pajunk GmbH Medizintechnologie · 1299-10-15
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
- false
- Commercial distribution status
- Not in Commercial Distribution
- Device description
- 1299-10-15
- Public device record key
- eaaf8809-42a9-41e6-8472-44afaa04243a
- Has serial number
- false
- Public version date
- 2026-08-03
- Commercial distribution end date
- 2026-07-31
- Is direct marking exempt
- true
- Public version number
- 5
- Labeler duns number
- 317654283
- Is labeled as no nrl
- false
- Is single use
- false
- Is otc
- false
- Version or model number
- 1299-10-15
- Has manufacturing date
- false
- Brand name
- FLOWTUBE HF
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Catalog number
- 1299-10-15
- Company name
- Pajunk GmbH Medizintechnologie
- Public version status
- Update
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2021-04-02
- Storage
- Type
- Storage Environment Temperature
- High
- Unit
- Degrees Celsius
- Value
- 30
- Low
- Unit
- Degrees Celsius
- Value
- 10
- Type
- Storage Environment Humidity
- High
- Unit
- Percent (%) Relative Humidity
- Value
- 65
- Low
- Unit
- Percent (%) Relative Humidity
- Value
- 10
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- true
- Sterilization methods
- Moist Heat or Steam Sterilization
- Identifiers
- ID
- 04048223083734
- Type
- Primary
- Issuing agency
- GS1
- ID
- 04048223006979
- Type
- Previous
- Issuing agency
- GS1
- Product codes
- Code
- GEI
- Name
- Electrosurgical, cutting & coagulation & accessories
- Harmonized identifiers (openFDA)
- Device name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4400
- Device class
- 2
- Premarket submissions
- Submission number
- K062047
- Supplement number
- 000
- Customer contacts
- Phone
- +1 770-493-6832
- info@pajunk-usa.com
- Gmdn terms
- Code
- 36136
- Name
- Haemostatic knife
- Implantable
- false
- Code status
- Active
- Definition
A hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device.