Identity
- Trade Name
- 2.0/2.4 Depth Gage, 70MM FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- 2.0/2.4 Depth Gage, 70MM EUDAMEDFDA UDI
- Model / Reference
- 09-281-000 EUDAMED03.319.002 FDA UDI
- Description
- 2.0/2.4 Depth Gage, 70MM FDA UDI
Identifiers
- Catalog Number
- 09-281-000 FDA UDI
- Primary DI / UDI-DI
- 00847538010374 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380328453L EUDAMED
- Direct Marketing DI
- 00847538010374 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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
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
2.0/2.4 Depth Gage, 70MM 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 | 08475380328453L | 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 f66738ad-b862-44c8-abce-6bf384e311a8 61 fields · synced Oct 7, 2026
- FDA UDI ab683b22-ed4e-4f09-aabc-ef5e389d1cdf 34 fields · synced May 30, 2026