Identity
- Trade Name
- HP Extraction Standard Removal Case FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- AA INSTRUMENT CASE OUTER EUDAMEDHP Extraction Standard Removal Case FDA UDI
- Model / Reference
- 87-1008 EUDAMEDFDA UDI
- Description
- HP Extraction Standard Removal Case FDA UDI
Identifiers
- Catalog Number
- 2011-03-048 FDA UDI
- Primary DI / UDI-DI
- 00847538008654 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380137302K EUDAMED
- Direct Marketing DI
- 00847538008654 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 2425a004-6c87-4f86-ad27-49f3e63efb13 61 fields · synced Jun 19, 2026
- FDA UDI 04b40078-dd9b-4794-8c1a-4d444cdadc65 34 fields · synced May 25, 2026