FDA.reportPublic FDA data

ACS

Primary DI
00191072135285
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
MECY13K
Device description
CYSTO PACK
Published
2021-05-10
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072135285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072135285001910721352851910721352850191072135285

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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
10195327465865Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327537302Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327544317Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327482886Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-10-15
10195327495756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-09-17
10195327479107Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327480264Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327481292Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327443726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-29
10195327449223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-09
10195327454401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-09
10195327442521Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-25
10195327272562Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327275440Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327279950Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327280055Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327265892Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327266073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327266356Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327418144Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327420420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327420895Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327423360Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327407650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-28
10195327402808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406097Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406103Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327407148Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327407728Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14