FDA.reportPublic FDA data

ACS

Primary DI
00191072190918
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LSRLMDCD
Device description
PACK D-C LH - 2082501
Published
2023-03-14
Public version status
New
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
PKFD and C tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKFD And C TrayUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072190918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072190918001910721909181910721909180191072190918

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA 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.

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
10198956586246CARDINAL HEALTHCardinal Health 200, LLCPKF2026-09-25
10198956384330CARDINAL HEALTHCardinal Health 200, LLCPKF2026-08-26
10198956529052CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-27
10198956537019CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-27
10198956527799CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-09
10198956423077CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956490949CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956491823CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956497658CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-08
10198956442467CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956482302CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956490536CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956487567CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10198956488502CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10195594785321CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-27
10195594804152CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-06
10195594808365CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594714628CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-09
10195594813642CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594821906CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594809140CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594814847CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594803599CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-02
10195594790059CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-29
10195594783594CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-26
10195594789336CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594790950CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594792329CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594781392CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-17
10195594729929CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-12