FDA.reportPublic FDA data

Halyard

Primary DI
10809160538012
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VAIC035-07_0006
Catalog number
VAIC035-07
Published
2026-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20809160538019PackageGS16In Commercial Distribution
10809160538012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053801920809160538019
1080916053801210809160538012

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, medicated, single-useA collection of various sterile ophthalmic surgical instruments, dressings, and the necessary materials which includes a pharmaceutical(s) intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). This is a single-use device.

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160536308HalyardVASF101-10_0001VASF101-102026-09-18
10809160536315HalyardVCIH001-03_0001VCIH001-032026-09-18
10809160536322HalyardVASF100-09_0001VASF100-092026-09-18
10809160536339HalyardVAHT027-16_0002VAHT027-162026-09-18
10809160536346HalyardVAHT021-14_0002VAHT021-142026-09-18
10809160536353HalyardVAHT024-14_0001VAHT024-142026-09-18
10809160536360HalyardVAHT011-12_0001VAHT011-122026-09-18
10809160536377HalyardVAHT013-17_0001VAHT013-172026-09-18
10809160536384HalyardVAHT017-07_0001VAHT017-072026-09-18
10809160536391HalyardVAHT028-12_0001VAHT028-122026-09-18
10809160536407HalyardVAHT026-21_0001VAHT026-212026-09-18
10809160536414HalyardVAHT019-18_0001VAHT019-182026-09-18
10809160536421HalyardVAHT016-06_0001VAHT016-062026-09-18
10809160536438HalyardVAHT023-13_0001VAHT023-132026-09-18
10809160536445HalyardVAHT006-13_0001VAHT006-132026-09-18
10809160536452HalyardVAHT031-19_0001VAHT031-192026-09-18
10809160536469HalyardVAHT030-18_0001VAHT030-182026-09-18
10809160536476HalyardVAHT032-22_0001VAHT032-222026-09-18
10809160536483HalyardWRNM042-16_0003WRNM042-162026-09-18
10809160536490HalyardEAMC102-10_0016EAMC102-102026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537657HalyardAVID MEDICAL, INC.OJK2026-09-19
10809160537718HalyardAVID MEDICAL, INC.OJK2026-09-19
10809160536919HalyardAVID MEDICAL, INC.OJK2026-09-18
10809160536926HalyardAVID MEDICAL, INC.OJK2026-09-18
B098AMS189300Aligned Medical SolutionsAligned Medical SolutionsOJK2026-09-18
B098AMS196590Aligned Medical SolutionsAligned Medical SolutionsOJK2026-09-18
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