FDA.reportPublic FDA data

ACS

Primary DI
00191072211279
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
PLDC33F
Device description
D&C PACK
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00191072211279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072211279001910722112791910722112790191072211279

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10198956475540CARDINAL HEALTHCardinal Health 200, LLCPKF2026-05-25
10198956484870CARDINAL HEALTHCardinal Health 200, LLCPKF2026-05-25
50198956385069CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-19
50198956407464CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-19
50198956412796CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-19
50198956313918CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-10
50198956333572CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-09
50198956407662CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-06
50198956332193CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956338652CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956389869CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956393880CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956247152CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-23
50198956366136CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-20
50198956381313CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-20
50198956378184CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-17
50198956350159CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-13
50198956351651CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-13
50198956317947CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-09
50198956326932CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-30
50198956254037CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-22
50198956304053CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-13
50198956307092CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-13
50198956269932CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-05
50198956284232CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-05
50198956296327CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-31
50198956300550CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-22
50198956296020CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-17
50198956251227CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-11
50198956289176CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-11