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
10809160541340HalyardMMBF002-03_0006MMBF002-032026-10-23
10809160541357HalyardVATX010-15_0013VATX010-152026-10-23
10809160541364HalyardMMBF007-04_0004MMBF007-042026-10-23
10809160541371HalyardMMBF006-07_0010MMBF006-072026-10-23
10809160541388HalyardMMBF017-05_0005MMBF017-052026-10-23
10809160541395HalyardMMBF027-01_0010MMBF027-012026-10-23
10809160541401HalyardMMBF024-02_0003MMBF024-022026-10-23
10809160541418HalyardMMBF016-06_0005MMBF016-062026-10-23
10809160541425HalyardMMBF008-04_0009MMBF008-042026-10-23
10809160541432HalyardMMBF010-04_0003MMBF010-042026-10-23
10809160541449HalyardMMBR003-02_0028MMBR003-022026-10-23
10809160541456HalyardMMBR007-02_0017MMBR007-022026-10-23
10809160541463HalyardMMBR002-02_0028MMBR002-022026-10-23
10809160541111HalyardMMSY007-02_0006MMSY007-022026-10-22
10809160541128HalyardSHAN099-01_0002SHAN099-012026-10-22
10809160541142HalyardOGHT55-02OGHT55-022026-10-22
10809160541159HalyardMMTN019-02_0016MMTN019-022026-10-22
10809160541166HalyardVATX013-13_0004VATX013-132026-10-22
10809160541173HalyardMMNP007-03_0010MMNP007-032026-10-22
10809160541180HalyardVATX015-10_0009VATX015-102026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956559820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956592872CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956604308CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956612464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956613386CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956613454CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956390799CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956584129CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956598812CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956611290CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956613195CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956604735CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-15
10198956564237CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-13
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956553361CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956562912CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567412CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567634CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956568082CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956579736CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956586734CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956589032CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956604469CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956538702CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956561717CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956564541CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06