FDA.reportPublic FDA data

Halyard

Primary DI
10809160528235
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SFSBPRT63-02_0002
Catalog number
SFSBPRT63-02
Published
2026-07-31
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
10809160528235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916052823510809160528235

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
10809160528365HalyardPSJH0015-02_0014PSJH0015-022026-08-03
10809160528372HalyardSFSAKOR36-02_0001SFSAKOR36-022026-08-03
10809160528389HalyardAKOR36-03_0002AKOR36-032026-08-03
10809160528396HalyardAKCR19-03_0003AKCR19-032026-08-03
10809160528402HalyardBMHT500-03_0005BMHT500-032026-08-03
10809160528419HalyardBMHU006-07_0007BMHU006-072026-08-03
10809160528426HalyardSELF137-05_0005SELF137-052026-08-03
10809160528433HalyardLANC039-31_0002LANC039-312026-08-03
10809160528440HalyardBMHT202-05_0004BMHT202-052026-08-03
10809160528457HalyardBMHT401-04_0006BMHT401-042026-08-03
10809160528464HalyardESCC82-02_0010ESCC82-022026-08-03
10809160528471HalyardLANC015-35_0011LANC015-352026-08-03
10809160528488HalyardBMHT400-03_0013BMHT400-032026-08-03
10809160528495HalyardBAMW001-03_0002BAMW001-032026-08-03
10809160528501HalyardQPTH29-02_0007QPTH29-022026-08-03
10809160528518HalyardSFSBMHU006-07_0001SFSBMHU006-072026-08-03
10809160528525HalyardHVBM219-04_0005HVBM219-042026-08-03
10809160528532HalyardSFSBAMW001-03_0001SFSBAMW001-032026-08-03
10809160528549HalyardMEEN42-03_0007MEEN42-032026-08-03
10809160528556HalyardDAMH300-03_0005DAMH300-032026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956544567CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10809160528228HalyardAVID MEDICAL, INC.OJK2026-07-31
10809160528143HalyardAVID MEDICAL, INC.OJK2026-07-30
10809160528082HalyardAVID MEDICAL, INC.OJK2026-07-29
10809160528105HalyardAVID MEDICAL, INC.OJK2026-07-29
10198956409712CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414471CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414501CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956470538CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956480490CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956520431CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956523722CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528581CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528628CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956529199CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956531994CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533363CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533448CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534759CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27