FDA.reportPublic FDA data

Halyard

Primary DI
10809160525302
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
EFCT02-05_0003
Catalog number
EFCT02-05
Published
2026-06-22
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
20809160525309PackageGS16In Commercial Distribution
10809160525302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052530920809160525309
1080916052530210809160525302

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
10809160526903HalyardBTMF007-06_0001BTMF007-062026-07-09
10809160526910HalyardDGBB41-02_0004DGBB41-022026-07-09
10809160526927HalyardBMHT200-03_0004BMHT200-032026-07-09
10809160526934HalyardSGCB56-03_0006SGCB56-032026-07-09
10809160526941HalyardSFSSHND415-02_0001SFSSHND415-022026-07-09
10809160526958HalyardLAKC010-08_0004LAKC010-082026-07-09
10809160526965HalyardSFSAKAH37-04_0001SFSAKAH37-042026-07-09
10809160526842HalyardAKCS54-03_0001AKCS54-032026-07-08
10809160526859HalyardDUAG11-01_0007DUAG11-012026-07-08
10809160526880HalyardSELF108-04_0005SELF108-042026-07-08
10809160526897HalyardHVSP206-05_0007HVSP206-052026-07-08
10809160526804HalyardSBHP01-02_0008SBHP01-022026-07-07
10809160526811HalyardAVMD027-02_0002AVMD027-022026-07-07
10809160526828HalyardSGGR61-04_0003SGGR61-042026-07-07
10809160526835HalyardSGCY35-02_0007SGCY35-022026-07-07
10809160526156HALYARDPVHM204-02PVHM204-022026-07-06
10809160526484HalyardLANC009-34_0008LANC009-342026-07-06
10809160526491HalyardSGMN13-04_0011SGMN13-042026-07-06
10809160526507HalyardAVMD054_0002AVMD0542026-07-06
10809160526514HalyardSHAN446-04_0002SHAN446-042026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956339132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956391949CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956394247CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956414532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956423213CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956513464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956521520CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956526006CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956526914CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956527362CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956527454CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956528475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956525733CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525801CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525900CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525917CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525931CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526051CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956527485CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
B098AMS193380Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-05
10198956390478CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956393783CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956511743CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956516212CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956227552CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956418899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08