Identity
- Trade Name
- glenoid reamer handle 48 FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 266838 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489668388 FDA UDI
- 510(k) Number
- K162068 FDA UDI
- FDA Product Code
- MBF FDA UDIKWS FDA UDIKWT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3670 FDA UDI888.3660 FDA UDI888.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
glenoid reamer handle 48 by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162068 also covers:
- Arrow pin extractor — FOURNITURES HOSPITALIERES INDUSTRIE
- canulated handle M8 — FOURNITURES HOSPITALIERES INDUSTRIE
- canulated punch 44 — FOURNITURES HOSPITALIERES INDUSTRIE
- canulated punch 44S — FOURNITURES HOSPITALIERES INDUSTRIE
- canulated punch 46 — FOURNITURES HOSPITALIERES INDUSTRIE
- canulated punch 48 — FOURNITURES HOSPITALIERES INDUSTRIE
- cutting guide pins — FOURNITURES HOSPITALIERES INDUSTRIE
- foret amovible D5 — FOURNITURES HOSPITALIERES INDUSTRIE
- foret conique canulé pour embase — FOURNITURES HOSPITALIERES INDUSTRIE
- foret Ø3.2mm — FOURNITURES HOSPITALIERES INDUSTRIE
- foret à butée canulé D5 — FOURNITURES HOSPITALIERES INDUSTRIE
- foret à butée canulé D5 long — FOURNITURES HOSPITALIERES INDUSTRIE
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
- Fournitures Hospitalieres Industrie
Sources (1)
- FDA UDI c4e76431-65b0-49b6-a081-652924334f50 33 fields · synced Jun 1, 2026