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Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing
INVOTEC INTERNATIONAL, INC. · Model 27-10001B · UDI-DI 00818501020898
10
510(k) clearances
202
Adverse events (3 deaths)
2
Recalls
105
Facilities
Description
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Blue 1.60" X 0.24" X 0.005"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-27 | GELITA MEDICAL GMBH | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. |
| 2006-07-11 | Porex Surgical, Inc. | Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material |
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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.