gRod Bender, In Situ, 13", Angled, Ø5.5mm, Left
by gSource, LLC
Ref gS 82.7717
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 | Number08403142HOLDINGDA 00840314270238 | Date19 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00840314270238 | Date20 Mar 2026 | 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- Withdrawn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
- gRod Bender, In Situ, 13", Angled, Ø5.5mm, Left EUDAMEDgSource GUDID
- Generic Name
- Manual orthopaedic bender, reusable
- Model / Ref / Catalog
- gS 82.7717
- Primary DI / UDI-DI
- 00840314270238
- Basic UDI-DI
- 08403142HOLDINGDA
- Direct Marketing DI
- 00840314270238
- FDA Product Code
- LXH
- EMDN Code
- L99 Surgical instruments, reusable - other
- GMDN Term
- Manual orthopaedic bender, reusable
- Device Class
- Class I
- Regulation Number
- 888.4540
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- US-MF-000004159
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Gsource, LLC.
Properties
Other properties (21)
- 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
- 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