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NOIR

Aesculap AG · Model GF005B · UDI-DI 04046964227233

GZX Prescription
10
510(k) clearances
67
Adverse events (1 deaths)
1
Recalls
137
Facilities

Description

NOIR Handle, 3 1/8", (80 mm), non-sterile, reusable, to be used with: GF025B, GF026B, GF027B, GF030B, GF031B, GF032B, GF033B, GF035B, GF036B, GF037B, GF038B, GF039B, GF045B, GF046B, GF047B, GF048B, GF04

Recalls

DateFirmReason
2007-01-22Medtronic Xomed, Inc.A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly ind

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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.