Straight Handle Universal Conn. A.o. Implantcast
FDA UDIEUDAMEDClass I (US FDA UDI)
by Hpf Srl
Identity
- Trade Name
- LIGE HÅNDTAG UNIVERSAL FORB. A.O. IMPLANTCAST EUDAMEDSTRAIGHT HANDLE UNIVERSAL CONN. A.O. IMPLANTCAST FDA UDI
- Generic Name
- Burring power tool attachment FDA UDI
- Model / Reference
- 75121701 EUDAMEDFDA UDIStraight reamer handle EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968719019 EUDAMEDFDA UDI
- Basic UDI-DI
- 805796871TF0032001U4 EUDAMED
- Direct Marketing DI
- 08057968719019 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Burring power tool attachment FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Burring power tool attachment
Straight Handle Universal Conn. A.o. Implantcast by Hpf Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 9b98016e-e42f-405a-abe1-ada77ee0bcc4 32 fields · synced Jul 11, 2026
- EUDAMED e51537ec-8f72-4917-a341-89a2cb4db419 61 fields · synced Jul 11, 2026