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Circular Osteotome
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0050050099Model Circular osteotome
by Hpf Srl
Identity
- Trade Name
- KRUHOVÝ OSTEOTOM EUDAMEDCIRCULAR OSTEOTOME FDA UDI
- Generic Name
- Chisel/osteotome blade handle FDA UDI
- Model / Reference
- H0050050099 EUDAMEDFDA UDICircular osteotome EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713581 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713581 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Chisel/osteotome blade handle 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: Chisel/osteotome blade handle
Circular Osteotome 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 ad0913fc-ba0f-43f6-b95f-d939c54d42d5 32 fields · synced Jun 18, 2026
- EUDAMED 5430afe2-1fcf-40fb-9d37-be515eaeae41 61 fields · synced Jun 18, 2026