FDA.report

ACS

Primary DI
00191072136374
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
FOCP03F
Device description
CYSTO PACK
Published
2021-07-21
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

Related Records

Product Codes

CodeName
NWUEndoscope introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072136374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072136374001910721363741910721363740191072136374

GMDN Terms

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
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

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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

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Primary DIBrandCompanyProduct codePublished
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50198956334869CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-23
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50198956403572CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-23
50198956406924CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-23
50198956420654CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-23
50198956425017CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-23
50198956325461CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-19
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50198956334111CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-19
50198956351934CARDINAL HEALTHCardinal Health 200, LLCNWU2026-03-19