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PDT, Inc.

PDT, INC. · Model R971 Just Be Nice Hygiene Kit · UDI-DI 00813677025005

EAXEMSEMNEKBEIXEJB
10
510(k) clearances
47
Adverse events
1
Recalls
371
Facilities

Description

Kit Includes: (R006) 11-12 Amazing Gracey™ Extended Reach Mini (R007) 13-14 Amazing Gracey™ Extended Reach Mini (R064) Columbia 13-14 (R130S) Jack B. Nimble® (R138) Montana Jack® (R224) 23 Explorer-Williams O Probe (R245) Cone Socket Mirror Handle (T050) #5 Mirror (15/16")

Recalls

DateFirmReason
2021-03-23Sunstar Americas, Inc.Product may be contaminated with Burkholderia contaminans.

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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.