Vitale 20044
by CellEra, LLC
Vitale 20044 is a device classified as Unclassified made by CellEra, LLC, cleared under FDA 510(k) K170077 on 30 Mar 2017 and listed in FDA GUDID since 16 May 2017 (UDI-DI B492200440), 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 | NumberB492200440 | Date16 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170077 | Date30 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K170077
Across registries
- FDA 510(k) K170077 decided 30 Mar 2017 Active
- FDA GUDID UDI-DI B492200440 listed 16 May 2017 Listed
Timeline
- Cleared FDA 510(k) K170077
- Listed FDA GUDID B492200440
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vitale
- Generic name
- Exudate-absorbent dressing, non-gel, antimicrobial
- Model / Ref / Catalog
- 20044
- Primary DI / UDI-DI
- B492200440
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Exudate-absorbent dressing, non-gel, antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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