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Instrument Case/Tray
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2217-50-067Model TRI-LOCK BPS W/GRIPTION Instrument Case/Tray
Identity
- Trade Name
- S-ROM FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Case/Tray EUDAMEDM-SPEC S-ROM 11/13 TRAY 40/44/48 FDA UDI
- Model / Reference
- TRI-LOCK BPS W/GRIPTION Instrument Case/Tray EUDAMED2217-50-067 EUDAMEDFDA UDI
- Description
- M-SPEC S-ROM 11/13 TRAY 40/44/48 FDA UDI
Identifiers
- Catalog Number
- 221750067 FDA UDI
- Primary DI / UDI-DI
- 10603295099147 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0002382 EUDAMED
- Direct Marketing DI
- 10603295099147 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
No
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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Instrument Case/Tray by DePuy Ireland UC — 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 | 0603295a0002382 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 6ca66232-6f1e-4b5c-a6d2-f84ee565e6cf 61 fields · synced Jul 31, 2026
- FDA UDI 8f685e1a-4029-4455-b621-6d44dabf9dad 35 fields · synced May 30, 2026