FDA.reportPublic FDA data

Austin Medical, Inc

Primary DI
00850017635586
Brand
Austin Medical, Inc
Company
AUSTIN MEDICAL
Model
AU-197S
Catalog number
AU-197S
Device description
CT Biopsy Tray
Published
2025-10-29
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
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017635586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017635586008500176355868500176355860850017635586

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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

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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017635944Austin Medical, IncAU-294SAU-294S2026-03-02
00850017635180Austin Medical, IncAU-102-OHSU2025-12-22
00850017635234Austin Medical, IncAU-94-OHSU-AAU-94-OHSU2025-12-22
00850017635272Austin Medical, IncAU-156S-BAU-156S-B2025-12-22
00850017635654Austin Medical, IncAU-141AU-1412025-12-22
00850017635661Austin Medical, IncAU-142AU-1422025-12-22
00850017635678Austin Medical, IncAU-143AU-1432025-12-22
00850017635685Austin Medical, IncAU-144AU-1442025-12-22
00850017635692Austin Medical, IncAU-145AU-1452025-12-22
00850017635708Austin Medical, IncAU-146AU-1462025-12-22
00850017635715Austin Medical, IncAU-147AU-1472025-12-22
00850017635722Austin Medical, IncAU-149AU-1492025-12-22
00850017635753Austin Medical, IncAU-152AU-1522025-12-22
00850017635760Austin Medical, IncAU-153-AAU-153-A2025-12-22
00850017635777Austin Medical, IncAU-162-AAU-162-A2025-12-22
00850017635791Austin Medical, IncAU-168S-UMDC-AAU-168S-UMDC-A2025-12-22
00850017635906Austin Medical, IncGST001-07GST001-072025-12-22
00850017635913Austin Medical, IncGST002-07GST002-072025-12-22
00850017635951Austin Medical, IncAU-0890N-OHAU-0890N-OH2025-12-22
00850017635968Austin Medical, IncAU-1017N-2AU-1017N-22025-12-22

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