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MAMMOGRAPHY GOWN

STANDARD TEXTILE CO., INC. · Model 74347089 · UDI-DI 00634916457643

FME
5
510(k) clearances
8
Adverse events (1 deaths)
1
Recalls
237
Facilities

Description

Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, single metal snap at front opening, OSFA

Recalls

DateFirmReason
2009-12-23Encompass Group LLCThe products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.