FDA.reportPublic FDA data

VERSANT VALUE

Primary DI
00612409943996
Brand
VERSANT VALUE
Company
FGX INTERNATIONAL INC.
Model
10307362.VER
Published
2022-06-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQZFrame, spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612409943996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612409943996006124099439966124099439960612409943996

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(401)231-3800Customerservices@fgxi.com

Regulatory Flags#

DUNS number
062312087
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00400000846316DISNEY THEME PARK10235644.DIS2022-06-28
00612409937469VERSANT SALSA10307139.VER2022-06-22
00612409940322VERSANT ROBERT MITCHEL10307203.VER2022-06-22
00612409941268VERSANT VALUE10306769.VER2022-06-22
00612409941541VERSANT SPLENDOR10307620.VER2022-06-22
00832886209624VERSANT CATERPILLAR10306749.VER2022-06-22
00832886209631VERSANT CATERPILLAR10306750.VER2022-06-22
00832886301359VERSANT CATERPILLAR10307313.VER2022-06-22
00612409942036VERSANT VALUE10307574.VER2022-06-22
00832886301199VERSANT CATERPILLAR10306836.VER2022-06-22
00000888831826POLAR OPTICS10601883.NVI2022-06-28
00000888832458XTRAVISION5013583-125.NVI2022-06-28
00000888832465XTRAVISION5013583-150.NVI2022-06-28
00000888832472XTRAVISION5013583-175.NVI2022-06-28
00000888832489XTRAVISION5013583-200.NVI2022-06-28
00000888832496XTRAVISION5013583-250.NVI2022-06-28
00000888832502XTRAVISION5013583-300.NVI2022-06-28
00000888832519XTRAVISION5013582-125.NVI2022-06-28
00000888832526XTRAVISION5013582-150.NVI2022-06-28
00000888832533XTRAVISION5013582-175.NVI2022-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435736028646ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736028721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090698ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090759ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504042976ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043010ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043058ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043096ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736088213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088275ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088398ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088596ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088794ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088916ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089036ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089098ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089159ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090810ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090872ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090933ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090995ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091114ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18