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"Drape Sheets, Tissue 2-ply, Blue, 40"" x 90"" "

Model 8150 · Dynarex Corporation · DI 00616784815039

FME — Gown, Examination · Class I · 21 CFR 880.6265

KME — Bedding, Disposable, Medical · Class I · 21 CFR 880.6060

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-04: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 4/device2023-07: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device0410020509101003071012
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-1001
2020-0201
2020-0501
2021-0903
2021-1002
2022-1002
2023-0304
2023-0701
2023-1002
2024-1202
This device (reports/month)Average device in FME, KME (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Dynarex Corporation

  • VAI 2017-03-02 Dynarex Corporation · 3 citations
  • VAI 2017-03-02 Dynarex Corporation · 3 citations
  • VAI 2014-03-31 Dynarex Corporation · 4 citations
  • VAI 2014-03-31 Dynarex Corporation · 4 citations
  • NAI 2011-12-20 Dynarex Corporation · 0 citations
  • NAI 2011-12-20 Dynarex Corporation · 0 citations