Home GUDID 00191072076151 ACS
Primary DI 00191072076151
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model SJBE44E
Device description BASIC EAR SJH
Published 2019-09-16
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 OJR Vacuum powered body fluid collection Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OJR Vacuum Powered Body Fluid Collection Kit General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191072076151 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 00191072076151 00191072076151 191072076151 0191072076151
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various sterile 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 00193489084613 Medline MEDLINE INDUSTRIES, INC. OJR 2022-07-12 00815277022187 Curaplex BOUND TREE MEDICAL, LLC OJR 2016-12-14