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Silicone Sheeting, non-sterile, blue
Spiggle & Theis Medizintechnik GmbH · Model 1780100-B · UDI-DI 04250381808085
LYA
Prescription
10
510(k) clearances
203
Adverse events (3 deaths)
2
Recalls
105
Facilities
Description
300 x 300 x 1.0 mm (900 cm²) 80 shore, 1 piece
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.