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RADIAL OSTEOTOME LATERAL BLADE 172x12 WITH SLOT
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 01.10.10.2070Model Radial osteotome blade
by Hpf Srl
Identity
- Trade Name
- RADIÁLNÍ OSTEOTOM BOČNÍ NŮŽ 172x12 S DRÁŽKOU EUDAMEDRADIAL OSTEOTOME LATERAL BLADE 172x12 WITH SLOT FDA UDI
- Generic Name
- Orthopaedic chisel blade FDA UDI
- Model / Reference
- 01.10.10.2070 EUDAMEDFDA UDIRadial osteotome blade EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055727372673 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08055727372673 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090404 OSTEOTOMES AND SCALPELS BLADES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic chisel blade 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 blade
RADIAL OSTEOTOME LATERAL BLADE 172x12 WITH SLOT 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 blade.
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- GSO GS1 Spinal System — UNIFIED SPINE, LLC · Class I
- MODIFIED BOX CHISEL — Biomet Orthopedics, Inc. · Class I
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 1347ffa1-9b83-472b-b4d4-f46e081565b8 32 fields · synced Jun 18, 2026
- EUDAMED f81ead37-d314-4585-9e02-fd30c0dd4c50 61 fields · synced Jun 18, 2026