FDA.reportPublic FDA data

ACS

Primary DI
00191072092298
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIBC55L
Device description
BASIC CYSTO (PS 078564)
Published
2020-09-24
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
NWUEndoscope introducer kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072092298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072092298001910720922981910720922980191072092298

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
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
00677964153617Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153624Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153631Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153648Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153655Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153662Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153679Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153686Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153693Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153709Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153716Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153723Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153730Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153747Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153754Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153761Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153778Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153785Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
10198956057005CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956358003CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956376953CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956441071CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956444508CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956454460CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956463042CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956463264CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956465183CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956469297CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956480889CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956484313CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25