ACETABULAR BLADE D64 mm LONG
FDA UDIEUDAMEDClass I (US FDA UDI)
by Hpf Srl
Identity
- Trade Name
- ACETABULÁRNÍ NŮŽ D64 mm EUDAMEDACETABULAR BLADE D64 mm LONG FDA UDI
- Generic Name
- Orthopaedic osteotome blade, reusable FDA UDI
- Model / Reference
- H0050450309 EUDAMEDFDA UDIAcetabular blade EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713284 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713284 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090404 OSTEOTOMES AND SCALPELS BLADES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome blade, reusable 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
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: Orthopaedic osteotome blade, reusable
ACETABULAR BLADE D64 mm LONG 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
MDD
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 2859b083-cec3-445e-9ce5-a679c98b1150 32 fields · synced Jun 18, 2026
- EUDAMED f3e4e842-ad8d-47da-90dd-baee92ea83cc 61 fields · synced Jun 18, 2026