Identity
- Trade Name
- FlexiGRAFT® FDA UDI
- Generic Name
- Tendon graft FDA UDI
- Device Name
- GraftLink TS (12x88 MM) FDA UDI
- Model / Reference
- FGLTS12088 FDA UDI
- Description
- GraftLink TS (12x88 MM) FDA UDI
Identifiers
- Catalog Number
- FGLTS FDA UDI
- Primary DI / UDI-DI
- 00889858610155 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Tendon graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 88 Millimeter FDA UDIOuter Diameter — 12.0 Millimeter FDA UDI
Category: Tendon graft
FlexiGRAFT® by Lifenet Health — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon graft.
- QuickGraft — Musculoskeletal Transplant Foundation · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
- FlexiGRAFT® — LIFENET HEALTH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lifenet Health
Sources (1)
- FDA UDI 4b0fb1e2-fc52-4457-b872-370311bb0bc5 36 fields · synced May 31, 2026