FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160250730
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
EACH1029-01_0007
Catalog number
EACH1029-01
Published
2019-08-07
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
20809160250737PackageGS14In Commercial Distribution
10809160250730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916025073720809160250737
1080916025073010809160250730

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
Combination product
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
10809160527047HalyardLMLP08-01_0002LMLP08-012026-07-14
10809160527061HalyardKDAU216-02_0011KDAU216-022026-07-14
10809160527085HalyardDULP19_0005DULP192026-07-14
10809160527092HalyardAKCY76-01_0005AKCY76-012026-07-14
10809160527009HalyardBMHT101-05_0001BMHT101-052026-07-13
10809160527016HalyardBMHT103-05_0001BMHT103-052026-07-13
10809160527023HalyardBMHT102-03_0001BMHT102-032026-07-13
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10
10809160526996HalyardBMHT110-04_0001BMHT110-042026-07-10
10809160526903HalyardBTMF007-06_0001BTMF007-062026-07-09
10809160526910HalyardDGBB41-02_0004DGBB41-022026-07-09
10809160526927HalyardBMHT200-03_0004BMHT200-032026-07-09
10809160526934HalyardSGCB56-03_0006SGCB56-032026-07-09
10809160526941HalyardSFSSHND415-02_0001SFSSHND415-022026-07-09
10809160526958HalyardLAKC010-08_0004LAKC010-082026-07-09
10809160526965HalyardSFSAKAH37-04_0001SFSAKAH37-042026-07-09
10809160526842HalyardAKCS54-03_0001AKCS54-032026-07-08
10809160526859HalyardDUAG11-01_0007DUAG11-012026-07-08
10809160526880HalyardSELF108-04_0005SELF108-042026-07-08
10809160526897HalyardHVSP206-05_0007HVSP206-052026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956513464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956521520CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956526006CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956526914CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956527362CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956527454CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956528475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956525733CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525801CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525900CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525917CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525931CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526051CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956527485CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
B098AMS193380Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-05
10198956390478CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956393783CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956511743CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10198956516212CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-23
10809160525302HalyardAVID MEDICAL, INC.OJK2026-06-22
10198956227552CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956418899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08