Asy-00670
Ref ASY-00670
Asy-00670 is a Class I device made by Integrity Implants Inc., registered in EUDAMED on 10 Jun 2022 (Basic UDI-DI B-00840200403269) and listed in FDA GUDID since 9 Nov 2020 (UDI-DI 00840200403269), active as of 23 Oct 2026.
Active
CE MDD
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/MDD EUDAMED | NumberB-00840200403269 00840200403269 | Date10 Jun 2022 | StatusActive |
| United States | GUDID listing GUDID | Number00840200403269 | Date9 Nov 2020 | StatusListed |
Official records
- EUDAMED public site B-00840200403269
- AccessGUDID record 00840200403269
Across registries
- EUDAMED Basic UDI-DI B-00840200403269 registered 10 Jun 2022 Active
- FDA GUDID UDI-DI 00840200403269 listed 9 Nov 2020 Listed
Timeline
- Listed FDA GUDID 00840200403269
- Registered EUDAMED B-00840200403269
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- FlareHawk Interbody Fusion System
- Generic name
- Arthroscopic access cannula, reusable
- Model / Ref / Catalog
- ASY-00670
- Primary DI / UDI-DI
- 00840200403269
- Basic UDI-DI
- B-00840200403269
- FDA product code
- LXH
- EMDN code
- L1907 Arthroscopic surgery cannulas, reusable
- GMDN term
- Arthroscopic access cannula, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under ARTHROSCOPIC SURGERY CANNULAS, REUSABLE.