Accessory Arm, Long, Red
by TeDan Surgical Innovations, Inc.
Part of a family of 70 devices: see the family page
Ref HS-0040
Accessory Arm, Long, Red (HS-0040) is a Class I device made by TeDan Surgical Innovations, Inc., registered in EUDAMED on 5 Apr 2022 (Basic UDI-DI 8430591ARMF8) and listed in FDA GUDID since 21 Aug 2017 (UDI-DI 00843059109542), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number8430591ARMF8 00843059109542 | Date5 Apr 2022 | StatusActive |
| United States | GUDID listing GUDID | Number00843059109542 | Date21 Aug 2017 | StatusListed |
Official records
- EUDAMED public site 8430591ARMF8
- AccessGUDID record 00843059109542
Across registries
- EUDAMED Basic UDI-DI 8430591ARMF8 registered 5 Apr 2022 Active
- FDA GUDID UDI-DI 00843059109542 listed 21 Aug 2017 Listed
Timeline
- Listed FDA GUDID 00843059109542
- Registered EUDAMED 8430591ARMF8
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Accessory Arm, Long, Red EUDAMEDTsi GUDID
- Generic name
- Surgical instrument assist arm system, manually-adjusted
- Device name
- Arm
- Model / reference
- HS-0040
- Primary DI / UDI-DI
- 00843059109542
- Basic UDI-DI
- 8430591ARMF8
- Direct marketing DI
- 00843059109542
- FDA product code
- FWZ
- EMDN code
- L0999 Orthopaedic and traumatological surgery instruments, reusable - other
- GMDN term
- Surgical instrument assist arm system, manually-adjusted
- Device class
- Class I
- Regulation number
- 878.4950
- EU registration type
- Standard device
- EU market of registration
- Austria
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- US-MF-000016933
- Authorised representative
- TeDan Surgical Innovations B.V. NL-AR-000002696
Similar devices in this category
Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.
- Trinity Acetabular Hip System with HXLPE Liners 299.760 by CORIN LTD
- APEX Knee System KR-40090 by OMNIlife science, Inc.
- APEX Knee System KS-9017R by OMNIlife science, Inc.
- Trinity Acetabular Hip System with HXLPE Liners 921.126 by CORIN LTD
- Neo Medical Pedicle Screw System SI-RS-00-14 by Neo Medical Inc.
- GAUTHIER BIOMEDICAL G170402 by Gauthier Biomedical, Inc.
- 234-500-225 by Stryker Corp.
- MicroFrance® MCEN35 by Integra Microfrance
- MicroFrance® M823C by Integra Microfrance
- Cable-Ready® 2232-03-02 00-2232-003-02 by Zimmer, Inc.