FDA.reportPublic FDA data

ACS

Primary DI
00191072190451
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
ESME42A
Device description
MINOR EYE PACK
Published
2023-03-07
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072190451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072190451001910721904511910721904510191072190451

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10198956345645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956394315CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956442313CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956453838CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956467316CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956470132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956474956CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956484962CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956486522CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956488281CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956488762CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956489042CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10809160521731HalyardAVID MEDICAL, INC.OJK2026-05-22
50198956370645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956378559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956390698CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416022CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416329CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416350CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956417296CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956421088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956421897CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956422177CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956422344CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956426847CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956428261CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956429299CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956429466CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956430998CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956330465CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-23