FDA.reportPublic FDA data

ACS

Primary DI
00191072099921
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UICR10K
Device description
SFCH CRANI PACK (PS 132432)
Published
2020-03-17
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072099921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072099921001910720999211910720999210191072099921

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
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Contains natural rubber latex
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
10198956379510CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956435643CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956507920CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956515635CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956541511CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956541528CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956592315CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956594760CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956595422CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956596245CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956554344CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956559714CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956560178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956576964CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956582521CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956582811CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956585959CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590144CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590373CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590540CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590694CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956591837CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956592193CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956592650CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956592667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956594821CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956595439CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10809160539224HalyardAVID MEDICAL, INC.OJG2026-09-29
10809160539286HALYARDAVID MEDICAL, INC.OJG2026-09-29
B098AMS14766C0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-09-26