SuperBall 12 degrees Reverse
by Arcuro Medical Ltd Israel GUDID
Product code GAT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850000630031 | Date30 Jun 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Specification
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
- Model / Ref / Catalog
- A, SBD-SB-12-012
- Primary DI / UDI-DI
- 00850000630031
- 510(k) Number
- FDA Product Code
- GAT
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
- Device Class
- Class II
- Regulation Number
- 878.5000
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
- MRI Safety
- MR Safe
Other devices from Arcuro Medical Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (1)
- FDA UDI 1df127bb-a964-4053-a038-958eae3be913