FDA.reportPublic FDA data

ACS

Primary DI
00191072094773
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LLCT16H
Device description
CT BIOPSY PACK
Published
2020-01-14
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
MJGDEVICE, PERCUTANEOUS, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072094773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072094773001910720947731910720947730191072094773

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA 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#

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
10198956133594CARDINAL HEALTHCardinal Health 200, LLCMJG2025-08-28
10198956127555CARDINAL HEALTHCardinal Health 200, LLCMJG2025-07-15
10198956116566CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-16
10198956084094CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-11
10197106926802CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10197106927991CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10198956017535CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956033542CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956078932CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-22
10198956015722CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-09
10198956010109CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-17
10198956040342CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-09
10198956001718CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-07
10197106850770CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-01
10198956024380CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-01
10197106838501CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-20
10197106980699CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-20
10197106983744CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-11
10197106963715CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-06
10197106917138CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-28
10197106962107CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-28
10197106933343CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-26
10197106945278CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-25
10197106910887CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-12
10197106924686CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-10
10197106924013CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-04
10197106802342CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106914250CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106905951CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-17
10197106887622CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-15