Crosstex International GCABL
by Crosstex International, Inc.
Crosstex International GCABL is a Class II device made by Crosstex International, Inc., cleared under FDA 510(k) K133070 on 22 Jun 2015 and listed in FDA GUDID since 11 Feb 2017 (UDI-DI 10732224120512), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10732224120512 | Date11 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133070 | Date22 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 10732224120512
- FDA 510(k) database K133070
Across registries
- FDA 510(k) K133070 decided 22 Jun 2015 Active
- FDA GUDID UDI-DI 10732224120512 listed 11 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K133070
- Listed FDA GUDID 10732224120512
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Crosstex International
- Generic name
- Surgical/medical respirator, non-antimicrobial, single-use
- Model / Ref / Catalog
- GCABL
- Description
- Advantage earloop mask/BLUE
- Primary DI / UDI-DI
- 10732224120512
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical respirator, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
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