← Back to catalogue
S-Rom Noiles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 63-4315Model S-ROM NOILES Depth limiter
Identity
- Trade Name
- S-ROM NOILES EUDAMEDS-ROM NOILES FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Device Name
- Depth limiter EUDAMEDS-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 30mm FDA UDI
- Model / Reference
- S-ROM NOILES Depth limiter EUDAMED63-4315 EUDAMEDFDA UDI
- Description
- S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 30mm FDA UDI
Identifiers
- Catalog Number
- 634315 FDA UDI
- Primary DI / UDI-DI
- 10603295181804 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005088X EUDAMED
- Direct Marketing DI
- 10603295181804 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument/implant depth limiter, 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
Yes
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
S-Rom Noiles 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 | 0603295a005088X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 62be19d4-5f22-4495-8fc4-e1f7da5fec54 61 fields · synced May 30, 2026
- FDA UDI 15e3facc-18c8-4518-9236-3c044847d10b 35 fields · synced May 30, 2026