FDA.reportPublic FDA data

Austin

Primary DI
00866001000339
Brand
Austin
Company
AUSTIN MEDICAL
Model
Au-10-143S
Catalog number
Au-10-143S
Device description
Total Capture Hysteroscopy Drape
Published
2018-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061422000SURGICAL DRAPESAustin Medical, Inc.2006-09-25KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866001000346PackageGS18In Commercial Distribution
00866001000339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866001000346008660010003468660010003460866001000346
00866001000339008660010003398660010003390866001000339

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Regulatory Flags#

DUNS number
010058700
Device count
1
Lot or batch
true
Expiration date on label
true
No 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29