El Capitan KZB110000
El Capitan KZB110000 is a Class II device made by Astura Medical, listed in FDA GUDID since 30 Jul 2021 (UDI-DI 00840085214752), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840085214752 | Date30 Jul 2021 | StatusListed |
Official records
- AccessGUDID record 00840085214752
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- El Capitan
- Generic name
- Surgical mallet
- Model / Ref / Catalog
- KZB110000
- Primary DI / UDI-DI
- 00840085214752
- FDA product code
- KWQ, OVD, MAX
- GMDN term
- Surgical mallet
- Device class
- Class II
- Regulation number
- 888.3060, 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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