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CHISEL OSTEOTOME BLADE 127x10 WITH HOLE
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0050208009Model Chisel osteotome blade with hole
by Hpf Srl
Identity
- Trade Name
- NŮŽ DLÁTA OSTEOTOMU 127x10 S OTVOREM EUDAMEDCHISEL OSTEOTOME BLADE 127x10 WITH HOLE FDA UDI
- Generic Name
- Orthopaedic chisel blade FDA UDI
- Model / Reference
- H0050208009 EUDAMEDFDA UDIChisel osteotome blade with hole EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713031 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713031 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090404 OSTEOTOMES AND SCALPELS BLADES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic chisel blade 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: Orthopaedic chisel blade
CHISEL OSTEOTOME BLADE 127x10 WITH HOLE by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 9995631d-ae44-4a04-9e0f-767da41749fa 32 fields · synced Jun 18, 2026
- EUDAMED 890e146d-a824-4e4d-a34c-c33b7c684055 61 fields · synced Jun 18, 2026