FDA.reportPublic FDA data

ACS

Primary DI
00191072241801
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
CIEY01G
Device description
EYE PREP PACK
Published
2026-02-19
Public version status
New
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072241801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072241801001910722418011910722418010191072241801

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
00191072241818ACSWEHF12B2026-02-19
00191072241856ACSRGLC12P2026-02-19
00191072241863ACSUIHN18AZ2026-02-19
00191072241870ACSBDAG39C2026-02-19
00191072241887ACSIHTK48AO2026-02-19
00191072241894ACSIHTR90N2026-02-19
00191072241900ACSUICA66AS2026-02-19
00191072241917ACSMWTK13AI2026-02-19
00191072241924ACSIHAR39AH2026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160543580HALYARDAVID MEDICAL, INC.OJK2026-11-03
10198956557840CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-29
10198956583207CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-29
10198956584365CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-29
10198956595880CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-29
10198956602298CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-29
10198956611245CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-29
10198956562905CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-26
10198956624528CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-26
B098AMS200500Aligned Medical SolutionsAligned Medical SolutionsOJK2026-10-26
10198956559820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956592872CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956604308CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956612464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956613386CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956613454CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956390799CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956584129CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956598812CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956611290CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956613195CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956604735CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-15
10198956564237CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-13
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956553361CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956562912CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567412CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567634CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956568082CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12