FDA.reportPublic FDA data

ACS

Primary DI
00191072160140
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
PKVT10E
Device description
VITRECTOMY PACK
Published
2022-02-05
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072160140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072160140001910721601401910721601400191072160140

GMDN Terms#

Term, Definition table
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 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
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
10193489212310Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489217391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489413038Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489417180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489421590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489422702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489424133Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489426007Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489427400Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489427950Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489428308Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489428384Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489429015Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489430707Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489438161Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489441918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489442588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489443028Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489444117Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489445770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489445930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489449112Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489449129Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489449471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489455670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489457209Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08