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MENTIO disposable ear specula
Spiggle & Theis Medizintechnik GmbH · Model 5001001 · UDI-DI 04250676730008
LYA
Prescription
10
510(k) clearances
203
Adverse events (3 deaths)
2
Recalls
105
Facilities
Description
plastic (PP), black, size/type 0 ID 2.1 mm, OD 3.4 mm, 200 pcs/box
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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