FDA.reportPublic FDA data

Halyard

Primary DI
10809160539804
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
IHES99_0001
Catalog number
IHES99
Published
2026-10-05
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
20809160539801PackageGS14In Commercial Distribution
10809160539804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053980120809160539801
1080916053980410809160539804

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
10809160539880HalyardHOCY12-01_0006HOCY12-012026-10-06
10809160539897HalyardDVSP33-01_0010DVSP33-012026-10-06
10809160539903HalyardMECS09-01_0008MECS09-012026-10-06
10809160539910HalyardJCHP48-01_0008JCHP48-012026-10-06
10809160539927HalyardMEVG08-01_0002MEVG08-012026-10-06
10809160539934HalyardWENE21-02_0004WENE21-022026-10-06
10809160539941HalyardSOAH30-01_0003SOAH30-012026-10-06
10809160539958HalyardBMHT030-06_0006BMHT030-062026-10-06
10809160539972HalyardDUCG46-01_0009DUCG46-012026-10-06
10809160539989HalyardPSTR001-02_0001PSTR001-022026-10-06
10809160540008HALYARDIHAR39-02IHAR39-022026-10-06
10809160539781HalyardDUUR19-03_0001DUUR19-032026-10-05
10809160539798HalyardRDLD061_0002RDLD0612026-10-05
10809160539811HALYARDBPDV50-02BPDV50-022026-10-05
10809160539828HALYARDSTOR11-03STOR11-032026-10-05
10809160539835HALYARDLMLP08-02LMLP08-022026-10-05
10809160539842HalyardDUUR19-03_0002DUUR19-032026-10-05
10809160539859HalyardDUCS29-03_0001DUCS29-032026-10-05
10809160539866HalyardAKNV91-01_0012AKNV91-012026-10-05
10809160539873HalyardRDLD014-07_0002RDLD014-072026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956538702CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956561717CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956564541CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956566873CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956589582CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956592780CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956589117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956595088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956517417CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956541955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956582330CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956588356CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956592674CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10809160539330HALYARDAVID MEDICAL, INC.OJK2026-09-29
10198956538795CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956565326CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956571136CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956581821CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956581845CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956588950CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956590380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956547575CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956554092CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956562899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956567306CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956571440CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956571709CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956584914CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956587595CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22