Identity
- Trade Name
- GAUTHIER BIOMEDICAL EUDAMEDFDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Device Name
- PROBE, LUMBAR STRAIGHT EUDAMEDFDA UDI
- Model / Reference
- 5161-00-5003 EUDAMED5161-00-5003 (G908146) FDA UDI
- Description
- PROBE, LUMBAR STRAIGHT FDA UDI
Identifiers
- Catalog Number
- 5161005003 FDA UDI
- Primary DI / UDI-DI
- 00858325005459 EUDAMEDFDA UDI
- Basic UDI-DI
- 008583250055161-00-5003PV EUDAMED
- Direct Marketing DI
- 00858325005459 EUDAMED
- FDA Product Code
- HXB FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
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 | 008583250055161-00-5003PV | 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 cede8729-af01-441e-82d5-eebfb9ccc95c 61 fields · synced Aug 1, 2026
- FDA UDI 60bbc735-554d-4c7e-a0ed-a5f2312c89f4 35 fields · synced May 30, 2026