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Osteotome - Spheres Locking Key
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0050051005Model OSTEOTOME - SPHERES LOCKING KEY
by Hpf Srl
Identity
- Trade Name
- OSTEOM - KLÍČ ZAJIŠTĚNÍ SFÉR EUDAMEDOSTEOTOME - SPHERES LOCKING KEY FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Model / Reference
- H0050051005 EUDAMEDFDA UDIOSTEOTOME - SPHERES LOCKING KEY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713642 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713642 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L098002 ORTHOPAEDIC INSTRUMENTS KEYS, REUSABLE EUDAMED
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
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: Surgical torque wrench, reusable
Osteotome - Spheres Locking Key by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical torque wrench, reusable.
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- X FIX — Biomet Orthopedics, Inc. · Class I
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hpf Srl
Sources (2)
- FDA UDI 6fd2fb72-b21e-4ff2-b0c8-efb691de4012 32 fields · synced Jun 19, 2026
- EUDAMED 55cd3af4-2f91-4ce6-bb23-9bb9db8080be 61 fields · synced Jun 19, 2026