FDA UDI
In Commercial Distribution
🇺🇸 United States
Affinity Home with accessories
DI: 07290017249063
·
Model: FG00016
·
TAVGER LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Affinity Home with accessories
- Primary DI
- 07290017249063
- Version / Model
- FG00016
- Company Name
- TAVGER LTD
- Labeler DUNS
- 533284357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-24
- Public Version
- 1
- Public Version Date
- 2022-04-01
- Public Version Status
- New
- Public Device Record Key
- fc6c8adb-6b6e-4b8e-85ff-3f15ae5278ed
Device Description
Affinity G.J.S with accessories MP
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 |
|---|---|---|---|---|
| 43667 | Surgical/orthopaedic lavage control unit | A mains electricity (AC-powered) device designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) by regulating a pulsatile jet of sterile fluid (typically saline). It is typically an electromechanical unit that includes a pump for irrigation/infusion of fluids, an extractor (frequently using vacuum), and controls for the rate of irrigation/infusion and withdrawal of the fluid; it usually operates with separate kits that include handpieces, tubing, and detachable tips (applicators) of various shapes and sizes for specific surgical applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017249063 | GS1 |