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ACS

Model UISL02B · AMERICAN CONTRACT SYSTEMS, INC. · DI 00191072107237

LYV — Label Or Tag, Sterile · Class I · 21 CFR 878.4800

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.

11222020-06: 0 reports for this device; peer average 2/device06
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0602
This device (reports/month)Average device in LYV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMERICAN CONTRACT SYSTEMS, INC.

  • Warning Letter 2024-11-01 American Contract Systems Inc
  • Warning Letter 2019-11-09 American Contract Systems, Inc.
  • Warning Letter 2018-11-06 American Contract Systems
  • Warning Letter 2011-04-21 American Contract Systems Inc
  • OAI 2025-06-02 American Contract Systems Inc · 4 citations
  • NAI 2025-04-17 American Contract Systems, Inc. · 0 citations
  • VAI 2025-03-21 American Contract Systems, Inc. · 1 citations
  • NAI 2025-01-16 American Contract Systems Inc. · 0 citations
  • OAI 2024-08-14 American Contract Systems Inc · 4 citations
  • VAI 2022-04-08 American Contract Systems, Inc. · 4 citations
  • VAI 2022-03-25 American Contract Systems · 4 citations
  • VAI 2022-03-02 American Contract Systems, Inc. · 4 citations
  • VAI 2021-12-08 American Contract Systems, Inc. · 0 citations
  • NAI 2021-12-07 American Contract Systems, Inc. · 0 citations
  • NAI 2021-12-03 American Contract Systems, Inc. · 0 citations
  • VAI 2021-09-24 American Contract Systems Inc. · 0 citations
  • OAI 2019-10-04 American Contract Systems, Inc. · 5 citations
  • OAI 2019-09-10 American Contract Systems, Inc. · 3 citations
  • OAI 2019-08-16 American Contract Systems, Inc. · 8 citations
  • OAI 2019-07-25 American Contract Systems · 4 citations
  • NAI 2019-04-01 American Contract Systems, Inc. · 0 citations
  • OAI 2018-10-02 American Contract Systems · 7 citations
  • VAI 2018-05-24 American Contract Systems, Inc. · 6 citations
  • VAI 2017-07-26 American Contract Systems, Inc. · 1 citations