FDA.reportPublic FDA data

Halyard

Primary DI
20809160463595
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
KLEC0002-15_0008
Catalog number
KLEC0002-15
Published
2026-03-02
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
20809160463595PackageGS16In Commercial Distribution
10809160463598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916046359520809160463595
1080916046359810809160463598

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.

Sterilization Methods#

Method table
Method

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
10809160523063HalyardSFSLVTJ65-01_0001SFSLVTJ65-012026-06-09
10809160523070HalyardLVTJ65-01_0011LVTJ65-012026-06-09
10809160523087HalyardSFSMSBM022-06_0003SFSMSBM022-062026-06-09
10809160523094HalyardAXOG2000-11_0001AXOG2000-112026-06-09
10809160523100HalyardACTK56-03_0009ACTK56-032026-06-09
10809160523117HalyardSGGY67-05_0003SGGY67-052026-06-09
10809160523124HalyardBMHT020-05_0001BMHT020-052026-06-09
10809160523131HalyardSHAN409-06_0004SHAN409-062026-06-09
10809160523148HalyardAMCH001-02_0002AMCH001-022026-06-09
10809160523162HalyardDUCD44-03_0003DUCD44-032026-06-09
10809160523179HalyardLLHT24-01_0006LLHT24-012026-06-09
10809160523186HalyardLMCV54-01_0002LMCV54-012026-06-09
10809160523193HalyardUICD62-01_0004UICD62-012026-06-09
10809160523209HalyardRCOH61-01_0007RCOH61-012026-06-09
10809160523216HalyardUICS88-01_0002UICS88-012026-06-09
10809160523223HalyardUIPD03-01_0005UIPD03-012026-06-09
10809160523230HalyardWILF002-23_0005WILF002-232026-06-09
10809160523247HalyardWILF002-23_0006WILF002-232026-06-09
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956227552CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956418899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
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10198956475441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956477551CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956489264CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956498556CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956501911CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956470507CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956490260CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956491960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956492776CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493001CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493377CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956495173CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956496569CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956499744CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956397682CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956417229CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956478992CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956487642CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10197106817643CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956351738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956407084CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956410145CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956418387CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421219CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956439559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01