FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160255186
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
NHPF011-06_0005
Catalog number
NHPF011-06
Published
2019-08-21
Public version status
New
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
20809160255183PackageGS16In Commercial Distribution
10809160255186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916025518320809160255183
1080916025518610809160255186

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.

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

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
B098AMS131930Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
B098AMS14577A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
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10198956385535CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956417434CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
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