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Sterile Drape
AVINGER, INC. · Model SD100 · UDI-DI 00851354004264
KKK
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
4
Facilities
Description
The Sterile Drape is designed to function as a protective barrier between the sterile and non-sterile environments during surgical procedures
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-07-28 | Cardinal Health 200, LLC | Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. |
| 2014-05-20 | Customed, Inc | Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to th |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.