S-Rom Noiles
by DePuy Ireland UC EUDAMEDGUDID
Active
Ref 63-4350
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0603295a002358K | Date23 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10603295181897 | Date24 Sep 2018 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Generic Name
- Orthopaedic reamer guide
- Device Name
- Reamer Guide
- Model / Ref / Catalog
- 63-4350, 634350
- Primary DI / UDI-DI
- 10603295181897
- Basic UDI-DI
- 0603295a002358K
- Direct Marketing DI
- 10603295181897
- FDA Product Code
- LXH
- EMDN Code
- L0922 Orthopaedic surgery guides, reusable
- GMDN Term
- Orthopaedic reamer guide
- Device Class
- Class I
- Regulation Number
- 888.4540
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No