Home GUDID 00191072164544 ACS
Primary DI 00191072164544
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model SLIM21F
Device description MPIA BIOPSY TRAY
Published 2022-03-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name FCH TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCH Tray, Biopsy, Without Biopsy Instruments Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191072164544 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00191072164544 00191072164544 191072164544 0191072164544
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 010334675 Device count 1 Premarket exempt true Kit true Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M78312011161 Diversatek Healthcare DIVERSATEK HEALTHCARE, INC. FCH 2025-11-14 00810185250370 Therapak Therapak LLC FCH 2025-08-11 00810185250431 Therapak Therapak LLC FCH 2025-08-11 00810185250455 Therapak Therapak LLC FCH 2025-08-11 00810185250530 Therapak Therapak LLC FCH 2025-08-11 00810185250394 Therapak Therapak LLC FCH 2025-08-04 20809160472030 Halyard AVID MEDICAL, INC. FCH 2025-07-02 00191072236067 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2025-01-31 00191072236098 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2025-01-31 00191072233714 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-12-19 M78312011101 Diversatek Healthcare DIVERSATEK HEALTHCARE, INC. FCH 2024-10-31 00191072231376 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-10-21 00191072230935 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-10-14 M78312011081 Diversatek Healthcare DIVERSATEK HEALTHCARE, INC. FCH 2024-06-07 00191072223982 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-05-08 00191072223999 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-05-08 00191072223616 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-05-03 00191072223111 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-04-26 00191072222145 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-04-15 00191072219077 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-03-04 00191072219534 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-03-04 00191072219855 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2024-03-04 M78312011061 Diversatek Healthcare DIVERSATEK HEALTHCARE, INC. FCH 2024-01-31 00191072213655 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2023-12-19 00191072212993 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2023-12-12 10849233013770 Busse Hospital Disposables ROBERT BUSSE & CO., INC. FCH 2023-12-12 00191072208316 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2023-10-12 00191072206077 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2023-09-27 00191072206114 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2023-09-27 00191072202246 ACS AMERICAN CONTRACT SYSTEMS, INC. FCH 2023-08-28