Identity
- Trade Name
- Osteotome EUDAMEDLife Instruments FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Osteotomes-Gouges-Chisels EUDAMEDSmith Peterson Osteotome 5/8" Str FDA UDI
- Model / Reference
- 750-0858-0 EUDAMEDFDA UDI
- Description
- Smith Peterson Osteotome 5/8" Str FDA UDI
Identifiers
- Primary DI / UDI-DI
- M930750085800 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M930005Q3 EUDAMED
- FDA Product Code
- HWM FDA UDI
- EMDN Code
- L090403 ORTHOPAEDIC SURGERY GOUGES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic osteotome
Life Instruments by Life Instrument Corporation — 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 |
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Manufacturer
- Manufacturer
- Life Instrument Corporation
Sources (2)
- FDA UDI 89a4b941-2fc2-4cc0-9077-5739a8f25516 33 fields · synced Jul 8, 2026
- EUDAMED b19451dd-6d87-4a6c-89c6-fd150ecc3092 61 fields · synced Jun 18, 2026