Lightbox Umbilical U100
Lightbox Umbilical U100 is a Class II device made by Avinger, Inc., listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004127), registry data as of 22 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 | Number00851354004127 | Date21 Mar 2019 | StatusListed |
Official records
- AccessGUDID record 00851354004127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Lightbox Umbilical
- Generic name
- Mechanical atherectomy system generator, mechanical output
- Model / Ref / Catalog
- U100
- Primary DI / UDI-DI
- 00851354004127
- FDA product code
- PDU
- GMDN term
- Mechanical atherectomy system generator, mechanical output
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
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