FDA.reportPublic FDA data

Halyard

Primary DI
10809160522318
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
EURO019-10_0001
Catalog number
EURO019-10
Published
2026-06-01
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
20809160522315PackageGS13In Commercial Distribution
10809160522318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052231520809160522315
1080916052231810809160522318

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
10809160522332HalyardEURO055_0005EURO0552026-06-02
10809160522349HalyardUSAR052-17_0004USAR052-172026-06-02
10809160522356HalyardWILF002-23_0003WILF002-232026-06-02
10809160522363HalyardSGRB86-04_0009SGRB86-042026-06-02
10809160522370HalyardWINN109-05_0015WINN109-052026-06-02
10809160522387HalyardONEL028-03_0007ONEL028-032026-06-02
10809160522394HalyardNAMC414-09_0004NAMC414-092026-06-02
10809160522400HalyardKAFB005-21_0005KAFB005-212026-06-02
10809160522417HalyardSGSP11-03_0003SGSP11-032026-06-02
10809160522424HalyardMEHY02O_0009MEHY02O2026-06-02
10809160522431HalyardBMHT033-02_0010BMHT033-022026-06-02
10809160522448HalyardDGLP47-02_0008DGLP47-022026-06-02
10809160522165HalyardEURO011-09_0003EURO011-092026-06-01
10809160522172HalyardWILF024-22_0001WILF024-222026-06-01
10809160522189HalyardWILF011-24_0001WILF011-242026-06-01
10809160522196HalyardSGRB86-04_0006SGRB86-042026-06-01
10809160522202HalyardWILF004-22_0001WILF004-222026-06-01
10809160522219HalyardWILF027-21_0001WILF027-212026-06-01
10809160522233HalyardAVMD023-03_0001AVMD023-032026-06-01
10809160522240HalyardWILF002-23_0001WILF002-232026-06-01

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Primary DI, Brand, Company table
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