Identity
- Trade Name
- Gouge EUDAMEDLife Instruments FDA UDI
- Generic Name
- Surgical gouge FDA UDI
- Device Name
- Osteotomes-Gouges-Chisels EUDAMEDHibbs Gouge 1" Cvd FDA UDI
- Model / Reference
- 753-0910-1 EUDAMEDFDA UDI
- Description
- Hibbs Gouge 1" Cvd FDA UDI
Identifiers
- Primary DI / UDI-DI
- M930753091010 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M930005Q3 EUDAMED
- FDA Product Code
- GDH FDA UDI
- EMDN Code
- L090403 ORTHOPAEDIC SURGERY GOUGES, REUSABLE EUDAMED
- GMDN Term
- Surgical gouge 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: Surgical gouge
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 1657ba1c-5845-4826-a556-07a764c25d2c 33 fields · synced Jun 19, 2026
- EUDAMED f2e68d05-4b8b-4828-b4b5-0284d4cdbde1 61 fields · synced Jun 19, 2026