FDA.report

Halyard

Primary DI
20809160414948
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
WAFB217-01_0004
Catalog number
WAFB217-01
Published
2024-01-03
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

Related Records

Contact Domains

Product Codes

CodeName
OJKEye tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160414948PackageGS16In Commercial Distribution
10809160414941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916041494820809160414948
1080916041494110809160414941

GMDN Terms

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

Contacts

PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

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 DIBrandModelCatalogPublished
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10198956345645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
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10198956484962CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
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10198956488281CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956488762CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956489042CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10809160521731HalyardAVID MEDICAL, INC.OJK2026-05-22
50198956370645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956378559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
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50198956421088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956421897CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956422177CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956422344CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956426847CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956428261CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956429299CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956429466CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956430998CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956330465CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-23