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Accessory Handle
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0034000299Model Accessory handle
by Hpf Srl
Identity
- Trade Name
- TILBEHØR HÅNDTAG EUDAMEDACCESSORY HANDLE FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Model / Reference
- H0034000299 EUDAMEDFDA UDIAccessory handle EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968716780 EUDAMEDFDA UDI
- Basic UDI-DI
- 805796871TF0032006UE EUDAMED
- Direct Marketing DI
- 08057968716780 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 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 implant impactor, reusable
Accessory Handle 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
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hpf Srl
Sources (2)
- FDA UDI c1589f73-06dd-432e-bc67-3d666a572637 32 fields · synced Jul 9, 2026
- EUDAMED 6a19c587-8fb1-424f-a840-e2327f42cdf0 61 fields · synced Jul 9, 2026