FDA.reportPublic FDA data

Halyard

Primary DI
20809160471576
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
RFEY50-01
Catalog number
RFEY50-01
Published
2025-07-02
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
20809160471576PackageGS19In Commercial Distribution
10809160471579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916047157620809160471576
1080916047157910809160471579

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods#

Method table
Method

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956345645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956394315CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956442313CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
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