Home GUDID 00850017635692 Austin Medical, Inc
Primary DI 00850017635692
Brand Austin Medical, Inc
Company AUSTIN MEDICAL
Model AU-145
Catalog number AU-145
Device description Skin Prep
Published 2025-12-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850017635692 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 00850017635692 00850017635692 850017635692 0850017635692
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.
Regulatory Flags# DUNS number 010058700 Device count 1 Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850017635944 Austin Medical, Inc AU-294S AU-294S 2026-03-02 00850017635180 Austin Medical, Inc AU-102-OHSU 2025-12-22 00850017635234 Austin Medical, Inc AU-94-OHSU-A AU-94-OHSU 2025-12-22 00850017635272 Austin Medical, Inc AU-156S-B AU-156S-B 2025-12-22 00850017635654 Austin Medical, Inc AU-141 AU-141 2025-12-22 00850017635661 Austin Medical, Inc AU-142 AU-142 2025-12-22 00850017635678 Austin Medical, Inc AU-143 AU-143 2025-12-22 00850017635685 Austin Medical, Inc AU-144 AU-144 2025-12-22 00850017635708 Austin Medical, Inc AU-146 AU-146 2025-12-22 00850017635715 Austin Medical, Inc AU-147 AU-147 2025-12-22 00850017635722 Austin Medical, Inc AU-149 AU-149 2025-12-22 00850017635753 Austin Medical, Inc AU-152 AU-152 2025-12-22 00850017635760 Austin Medical, Inc AU-153-A AU-153-A 2025-12-22 00850017635777 Austin Medical, Inc AU-162-A AU-162-A 2025-12-22 00850017635791 Austin Medical, Inc AU-168S-UMDC-A AU-168S-UMDC-A 2025-12-22 00850017635906 Austin Medical, Inc GST001-07 GST001-07 2025-12-22 00850017635913 Austin Medical, Inc GST002-07 GST002-07 2025-12-22 00850017635951 Austin Medical, Inc AU-0890N-OH AU-0890N-OH 2025-12-22 00850017635968 Austin Medical, Inc AU-1017N-2 AU-1017N-2 2025-12-22 00850017635975 Austin Medical, Inc AU-0849N-OH AU-0849N-OH 2025-12-22