Identity
- Trade Name
- GAUTHIER BIOMEDICAL EUDAMEDFDA UDI
- Generic Name
- Surgical instrument handle, torque-limiting FDA UDI
- Device Name
- TORQUE LIMITER, RATCHET 11,3 NM EUDAMEDTORQUE LIMITER, RATCHET 11.3NM FDA UDI
- Model / Reference
- 5161-00-5048 EUDAMED5161-00-5048 (G919509) FDA UDI
- Description
- TORQUE LIMITER, RATCHET 11.3NM FDA UDI
Identifiers
- Catalog Number
- 5161005048 FDA UDI
- Primary DI / UDI-DI
- 00858325005688 EUDAMEDFDA UDI
- Basic UDI-DI
- 008583250055161-00-5048QK EUDAMED
- Direct Marketing DI
- 00858325005688 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gauthier Biomedical by Gauthier Biomedical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 008583250055161-00-5048QK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gauthier Biomedical, Inc.
- EUDAMED SRN
- US-MF-000015766
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 5f8027e7-7025-4c5b-9f7a-50df1215b10c 61 fields · synced Jul 11, 2026
- FDA UDI 22b4d825-2229-4aec-b27f-9c6f18905c78 35 fields · synced May 30, 2026