FDA.reportPublic FDA data

Halyard

Primary DI
10809160532003
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SFSEAMC114-07_0001
Catalog number
SFSEAMC114-07
Published
2026-08-27
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
10809160532003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053200310809160532003

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
10809160531853HalyardDGAL24-03_0010DGAL24-032026-08-27
10809160531860HalyardDGBB41-02_0006DGBB41-022026-08-27
10809160531877HalyardDGIV63_0008DGIV632026-08-27
10809160531884HalyardDUAD22-01_0004DUAD22-012026-08-27
10809160531891HalyardDUCC54_0009DUCC542026-08-27
10809160531907HalyardDUEC27-01_0004DUEC27-012026-08-27
10809160531914HalyardSJGH109-07_0007SJGH109-072026-08-27
10809160531921HalyardSFSEURO028-07_0001SFSEURO028-072026-08-27
10809160531938HalyardSHND415-02_0001SHND415-022026-08-27
10809160531945HalyardSOTJ41-01_0007SOTJ41-012026-08-27
10809160531952HalyardNAMC425-08_0013NAMC425-082026-08-27
10809160531969HalyardWAFB224-03_0007WAFB224-032026-08-27
10809160531976HalyardSFSBAAK106-15_0001SFSBAAK106-152026-08-27
10809160531983HalyardSFSEABF007-15_0001SFSEABF007-152026-08-27
10809160531990HalyardSFSBUAH026-24_0001SFSBUAH026-242026-08-27
10809160532010HalyardWRNM004-18_0004WRNM004-182026-08-27
10809160532027HalyardEURO002-11_0005EURO002-112026-08-27
10809160532034HalyardSFSEURO010-10_0001SFSEURO010-102026-08-27
10809160532041HalyardEURO013-11_0005EURO013-112026-08-27
10809160532058HalyardSFSMAAH024-02_0001SFSMAAH024-022026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956555129CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-18
10198956475090CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956510579CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956542624CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956544475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956544543CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956545281CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956546462CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956548749CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956554559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956414884CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956416222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956529076CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956534230CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956536661CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538016CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538771CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540750CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540798CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31