Identity
- Trade Name
- Acetabular Gouge, 56mm FDA UDI
- Generic Name
- Surgical gouge FDA UDI
- Device Name
- Angled Gouge EUDAMEDAcetabular Gouge, 56mm FDA UDI
- Model / Reference
- 10-059-400 EUDAMEDFDA UDI
- Description
- Acetabular Gouge, 56mm FDA UDI
Identifiers
- Catalog Number
- 2709-02-003;00-9986-020-12;430038 FDA UDI
- Primary DI / UDI-DI
- 00847538007886 EUDAMEDFDA UDI
- Basic UDI-DI
- 084753803509036 EUDAMED
- Direct Marketing DI
- 00847538007886 EUDAMED
- FDA Product Code
- LXH 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
- 888.4540 FDA UDI
- Market of Registration
- Ireland 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
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
Angled Gouge by Symmetry Medical Manufacturing, 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 | 084753803509036 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Medical Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000025394
- Authorised Representative
- SYMMETRY MEDICAL POLYVAC FR-AR-000003187
Sources (2)
- EUDAMED 3b555959-1d90-423c-9691-e409bbddfd7a 61 fields · synced Jun 20, 2026
- FDA UDI 4d82ecbd-56f0-4214-86d9-1ebf964b062c 34 fields · synced May 30, 2026