FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable tips box
DI: 07290017249018
·
Model: FG00006
·
TAVGER LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable tips box
- Primary DI
- 07290017249018
- Version / Model
- FG00006
- Company Name
- TAVGER LTD
- Labeler DUNS
- 533284357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-07
- Public Version
- 5
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 2dfafbd1-2c37-4a91-abd9-56cda88af0a7
Device Description
Affinity is a device used to clean a tissue (skin) by a tiny jets of sterile fluid. The device consists of tip with the nozzles arragement, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the nozzles, such as an electric roller pump.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQH | Lavage, Jet | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47891 | Surgical irrigation system nozzle | A surgically-invasive device designed to be attached to the distal end of a lavage system or kit handpiece to intraoperatively function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site; it may in addition perform aspiration (suction). It is available in many designs (e.g., fan spray, built-in filter, splash shield, brush); however, it is not a single-hole cannula/tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017249018 | GS1 | ||||
| Package | 17290017249022 | GS1 | box | 10 | In Commercial Distribution |