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Straight Handle For Delta Cup Extraction
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0050052599Model Handle for cup extraction
by Hpf Srl
Identity
- Trade Name
- ROVNÁ RUKOJEŤ PRO EXTRAKCI DELTA KOŠÍČKU EUDAMEDSTRAIGHT HANDLE FOR DELTA CUP EXTRACTION FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Model / Reference
- H0050052599 EUDAMEDFDA UDIHandle for cup extraction EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713659 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713659 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091101 ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic chisel 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
Straight Handle For Delta Cup Extraction by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic chisel.
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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 346b8da6-c347-4e14-9012-95654f2bf216 32 fields · synced Jun 20, 2026
- EUDAMED db38b0cd-b8d6-4e44-ae50-6679d4a0aace 61 fields · synced Jun 20, 2026