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Disposable Applicator Cover
Regenesis Biomedical, Inc. · Model PVTC30 · UDI-DI 20868924000018
ILX
Prescription
10
510(k) clearances
9
Adverse events
1
Recalls
7
Facilities
Description
Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-09-29 | Regenesis Biomedical Inc | In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio f |
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