Identity
- Trade Name
- CHISEL OSTEOTOME BLADE 76x12 WITH SLOT FDA UDI
- Generic Name
- Orthopaedic chisel blade FDA UDI
- Model / Reference
- H0050300709 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057968712751 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic chisel blade 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
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
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: Orthopaedic chisel blade
CHISEL OSTEOTOME BLADE 76x12 WITH SLOT by Hpf Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic chisel blade.
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- Intramedullary Internal Chisel — Biomet Orthopedics, Inc. · Class I
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- MODIFIED BOX CHISEL — Biomet Orthopedics, Inc. · Class I
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
- Hpf Srl
Sources (1)
- FDA UDI 6efd9132-1df9-494f-83a2-275efa8e3fe7 32 fields · synced Jun 6, 2026