Identity
- Trade Name
- Case 2 Complete FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- AA INSTRUMENT CASE OUTER EUDAMEDCase 2 Complete FDA UDI
- Model / Reference
- 87-1178 EUDAMED2500-00-794 FDA UDI
- Description
- Case 2 Complete FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817766026461 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380137302K EUDAMED
- Direct Marketing DI
- 00817766026461 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
No
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
Aa Instrument Case Outer 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 | 08475380137302K | 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 092fbb71-fbc5-4846-ba21-9c4ab1e442f7 61 fields · synced Aug 2, 2026
- FDA UDI 7829ad0f-4146-405c-9185-05fe0b7ebd82 33 fields · synced May 30, 2026