FDA.report

Halyard

Primary DI
20809160345945
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
MAMC269-01_0001
Catalog number
MAMC269-01
Published
2021-02-26
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
20809160345945PackageGS13In Commercial Distribution
10809160345948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916034594520809160345945
1080916034594810809160345948

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
true
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
true
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
10198956394315CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
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10198956453838CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956467316CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956470132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956474956CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956484962CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956486522CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
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
50198956390698CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416022CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416329CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416350CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956417296CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
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