Home GUDID 00191072132390 ACS
Primary DI 00191072132390
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model EYVT09E
Device description VITRECTOMY PACK
Published 2021-04-07
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 QDY Vitrectomy kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QDY Vitrectomy Kit Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191072132390 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 00191072132390 00191072132390 191072132390 0191072132390
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 00191072130808 ACS AMERICAN CONTRACT SYSTEMS, INC. QDY 2021-04-07 00191072122100 ACS AMERICAN CONTRACT SYSTEMS, INC. QDY 2021-01-27 00191072077493 ACS AMERICAN CONTRACT SYSTEMS, INC. QDY 2019-09-16