Spotlight Access System
by Medos International SARL 64 variants
Ref 292906002Model Spotlight Instruments Dilators and Retractors
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0705034a000876A 10705034225821 | Date15 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10705034225821 | Date31 Dec 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Spotlight Access System EUDAMEDSpotlight GUDID
- Generic Name
- Nerve/vessel retractor
- Device Name
- Spotlight Instruments Hook Retractor
- Model / Ref / Catalog
- Spotlight Instruments Dilators and Retractors, 292906002
- Primary DI / UDI-DI
- 10705034225821
- Basic UDI-DI
- 0705034a000876A
- Direct Marketing DI
- 10705034225821
- FDA Product Code
- GDG
- EMDN Code
- L0915 Spreaders and retractors for orthopaedic surgery, reusable
- GMDN Term
- Nerve/vessel retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Market of Registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- CH-MF-000014268
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Medos International SARL
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No