Expedium Spine System
by Medos International SARL 234 variants
Ref 279763595Model Expedium Reusable Instruments for Insertion and Extraction
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 | Number0705034a001075P | Date17 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10705034201016 | 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- Withdrawn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
- Expedium Spine System EUDAMEDExpedium GUDID
- Generic Name
- Orthopaedic implantation sleeve, reusable
- Device Name
- Expedium Reusable Instruments for Insertion and Extraction
- Model / Ref / Catalog
- Expedium Reusable Instruments for Insertion and Extraction, 279763595
- Primary DI / UDI-DI
- 10705034201016
- Basic UDI-DI
- 0705034a001075P
- Direct Marketing DI
- 10705034201016
- FDA Product Code
- GEA
- EMDN Code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- GMDN Term
- Orthopaedic implantation sleeve, reusable
- 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