FDA.reportPublic FDA data

ACS

Primary DI
00191072142832
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIVT47AL
Device description
VITRECTOMY SUPPLY (PS 907699)
Published
2021-08-10
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
MLZVitrectomy, instrument cutter
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLZVitrectomy, Instrument CutterOphthalmic2
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072142832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072142832001910721428321910721428320191072142832

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
10198956561489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956561588CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956562882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563391CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563667CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956566897CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956567191CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956568617CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956569096CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956569218CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570368CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570443CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570542CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570832CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10809160532874HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532904HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532959HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532003HalyardAVID MEDICAL, INC.OJK2026-08-27
10809160532102HalyardAVID MEDICAL, INC.OJK2026-08-27
10198956417533CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956478947CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956503069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956556539CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956561236CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956563360CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956565135CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10809160531839HalyardAVID MEDICAL, INC.OJK2026-08-26
B098AMS17526A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-08-23
10809160530733HalyardAVID MEDICAL, INC.OJK2026-08-19