Home GUDID 00191072174307 ACS
Primary DI 00191072174307
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model MEBP17K
Device description BIOPSY KIT
Published 2022-08-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 00191072174307 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 00191072174307 00191072174307 191072174307 0191072174307
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 010334675 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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