Identity
- Trade Name
- CoLink FDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- CoLink Bone Graft Harvester, 6mm - Sterile, Disposable FDA UDI
- Model / Reference
- G05 S1006 FDA UDI
- Description
- CoLink Bone Graft Harvester, 6mm - Sterile, Disposable FDA UDI
Identifiers
- Catalog Number
- G05 S1006 FDA UDI
- Primary DI / UDI-DI
- 00810021860251 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone trephine, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone trephine, reusable
CoLink by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
Sources (1)
- FDA UDI 8764c1a3-8dfe-452d-811a-f0f299e7863d 35 fields · synced May 30, 2026