FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160209103
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
GVVA010-04_0003
Catalog number
GVVA010-04
Published
2018-09-12
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
10809160209103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916020910310809160209103

GMDN Terms#

Term, Definition table
TermDefinition
Retinal optical coherence tomography systemAn assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.

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
10809160539002HalyardMAMC223-14_0003MAMC223-142026-09-25
10809160539040HalyardEURO005-09_0005EURO005-092026-09-25
10809160539057HalyardEURO003-10_0005EURO003-102026-09-25
10809160539064HalyardEURO003-11_0002EURO003-112026-09-25
10809160539071HalyardEURO005-10_0002EURO005-102026-09-25
10809160539088HalyardEURO006-10_0002EURO006-102026-09-25
10809160539095HalyardEURO006-09_0001EURO006-092026-09-25
10809160539101HalyardHVBM205-04_0005HVBM205-042026-09-25
10809160539118HalyardWINN117-05_0014WINN117-052026-09-25
10809160538920HALYARDBPEN95-02BPEN95-022026-09-24
10809160538944HalyardMAMC221-16_0031MAMC221-162026-09-24
10809160538951HalyardJACK410-11_0008JACK410-112026-09-24
10809160538975HalyardWBAM044-04_0003WBAM044-042026-09-24
10809160538982HalyardSWMR007-04_0008SWMR007-042026-09-24
10809160538586HalyardGBDV49-02_0011GBDV49-022026-09-22
10809160538593HalyardBPTJ33-02_0019BPTJ33-022026-09-22
10809160538616HalyardHVBM201-06_0005HVBM201-062026-09-22
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538647HalyardWRNM015-12_0006WRNM015-122026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956538795CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956565326CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956571136CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956581821CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956581845CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956588950CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956590380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956547575CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956554092CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956562899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956567306CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956571440CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956571709CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956584914CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956587595CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956588790CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956589162CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956373198CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956481961CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956577008CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956580879CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956580886CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956583948CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10809160538159HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538166HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538203HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538524HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538012HalyardAVID MEDICAL, INC.OJK2026-09-20
10809160537657HalyardAVID MEDICAL, INC.OJK2026-09-19
10809160537718HalyardAVID MEDICAL, INC.OJK2026-09-19