Identity
- Trade Name
- alésoir Ø8 AO FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 266319 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489663192 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
alésoir Ø8 AO 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
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- D5 M3, 5 MIXED CONNEXION SCREW — FOURNITURES HOSPITALIERES INDUSTRIE
- D7 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D8 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D9 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL LEFT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL RIGHT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- DRILL TIP 2, 5 GUIDE — FOURNITURES HOSPITALIERES INDUSTRIE
- ECARTEUR DE CHAIR A ERGOT — FOURNITURES HOSPITALIERES INDUSTRIE
K033510 also covers:
- AXE DE MASSELOTTE — FOURNITURES HOSPITALIERES INDUSTRIE
- CANULE COURTE — FOURNITURES HOSPITALIERES INDUSTRIE
- CONTAINER 550X265X125 — FOURNITURES HOSPITALIERES INDUSTRIE
- D5 M3, 5 MIXED CONNEXION SCREW — FOURNITURES HOSPITALIERES INDUSTRIE
- D7 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D8 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- D9 REAMER WITH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL LEFT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- DISTAL RIGHT JIG — FOURNITURES HOSPITALIERES INDUSTRIE
- DRILL TIP 2, 5 GUIDE — FOURNITURES HOSPITALIERES INDUSTRIE
- ECARTEUR DE CHAIR A ERGOT — FOURNITURES HOSPITALIERES INDUSTRIE
- FORET A BUTEE D4.5 EMBOUT AO — 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 602ca4dd-2be5-45dc-947b-7eed4dea6e75 33 fields · synced Jun 1, 2026