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Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit

Revian, Inc. · Model 10000-12722 · UDI-DI 00850003374130

OAP
1
510(k) clearances
34
Adverse events
1
Recalls
76
Facilities

Description

The Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who have lost or misplaced their Magnetic Micro-USB Connector or Magnetic Cable originally supplied with the REVIAN Red Device.

Recalls

DateFirmReason
2022-09-01OMM Imports, Inc. dba Zero GravityThe firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information

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Data 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.