Sirion GB224016A
by Astura Medical GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840085224447 | Date8 Jul 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Sirion
- Generic Name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- GB224016A
- Primary DI / UDI-DI
- 00840085224447
- FDA Product Code
- OVD, MAX, KWQ
- GMDN Term
- Metallic spinal interbody fusion cage
- Device Class
- Class II
- Regulation Number
- 888.3080, 888.3060
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Width — 22 MillimeterHeight — 16 MillimeterAngle — 0 degreeLength — 40 Millimeter
Other devices from Astura Medical
Properties
Other properties (10)
- Sterile: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No