FDA.reportPublic FDA data

ACS

Primary DI
00191072118837
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
BLUB95G
Device description
ULTRASOUND BREAST BIOPSY TRAY
Published
2020-10-30
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
00191072118837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072118837001910721188371910721188370191072118837

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191072241948ACSAMMV04AE2026-03-24
00191072241962ACSFDCR00AE2026-03-24
00191072241979ACSLKTK16AB2026-03-24
00191072241986ACSLKTH15W2026-03-24
00191072241993ACSFDTH08AJ2026-03-24
00191072242006ACSFDTK07AH2026-03-24
00191072242013ACSFDKA44S2026-03-24
00191072242020ACSFDSA15N2026-03-24
00191072242037ACSBPHA89E2026-03-24
00191072241757ACSSPSA58S2026-02-19
00191072241764ACSLLGT12F2026-02-19
00191072241801ACSCIEY01G2026-02-19
00191072241818ACSWEHF12B2026-02-19
00191072241856ACSRGLC12P2026-02-19
00191072241863ACSUIHN18AZ2026-02-19
00191072241870ACSBDAG39C2026-02-19
00191072241887ACSIHTK48AO2026-02-19
00191072241894ACSIHTR90N2026-02-19
00191072241900ACSUICA66AS2026-02-19
00191072241917ACSMWTK13AI2026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160394471MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-11-04
10809160543689HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-11-04
10809160543696HalyardAVID MEDICAL, INC.LRO2026-11-04
10809160543702HalyardAVID MEDICAL, INC.LRO2026-11-04
10809160543764HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-11-04
10885632543418SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-11-04
10885632543456SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-11-04
B098AMS195080Aligned Medical SolutionsAligned Medical SolutionsLRO2026-11-04
10198956548800CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956559851CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956582019CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956614406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956616455CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956618671CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956619494CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956619685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956624474CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956625976CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10809160542972HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160542989HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160542996HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543009HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543016HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543030HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543047HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543054HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543061HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543085HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543092HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543108HalyardAVID MEDICAL, INC.LRO2026-11-03