FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160209882
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
VAOR023-01_0002
Catalog number
VAOR023-01
Published
2018-09-18
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
20809160209889PackageGS16In Commercial Distribution
10809160209882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916020988920809160209889
1080916020988210809160209882

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photodisruptionA mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.

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
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10198956390799CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956584129CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
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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