FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160049808
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
WILF013-28_0005
Catalog number
WILF013-28
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
20809160049805PackageGS14In Commercial Distribution
10809160049808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916004980520809160049805
1080916004980810809160049808

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153AVIDComplaints@Owens-Minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527719HalyardKOOT801-03_0002KOOT801-032026-07-22
10809160527726HalyardLDSF0001_0004LDSF00012026-07-22
10809160527733HalyardLDSF0002_0002LDSF00022026-07-22
10809160527740HalyardLDSF0003_0002LDSF00032026-07-22
10809160527597HalyardBPTJ33-01_0006BPTJ33-012026-07-21
10809160527603HALYARDPVHM223-02PVHM223-022026-07-21
10809160527610HALYARDPVHM221-02PVHM221-022026-07-21
10809160527627HalyardHVBM208-02_0005HVBM208-022026-07-21
10809160527634HalyardBPMY56-02BPMY56-022026-07-21
10809160527641HalyardNHJV6000-22_0006NHJV6000-222026-07-21
10809160527658HalyardKOOT800-01_0003KOOT800-012026-07-21
10809160527672HalyardSHND401-05_0010SHND401-052026-07-21
10809160527689HalyardMEEP10-01_0008MEEP10-012026-07-21
10809160527696HalyardHVBM222-02_0003HVBM222-022026-07-21
10809160527702HalyardSGGR61-04_0002SGGR61-042026-07-21
10809160527542HalyardUSAR053-16_0001USAR053-162026-07-20
10809160527559HalyardSAMM034-21_0001SAMM034-212026-07-20
10809160527566HalyardWILF003-24_0004WILF003-242026-07-20
10809160527573HalyardAVMD057_0001AVMD0572026-07-20
10809160527580HalyardSAMM066-18_0001SAMM066-182026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956385535CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
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10198956418622CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956484986CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956489882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956498495CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956518513CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956526013CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956529069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956531222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532175CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532694CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533981CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
B098AMS192180Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-19
10198956382930CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956390546CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956516335CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956519626CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956529441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956530584CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
B098AMS193400Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-12
10198956339132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956391949CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956394247CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956414532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956423213CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09