FDA.reportPublic FDA data

VERSANT VALUE

Primary DI
00612409936080
Brand
VERSANT VALUE
Company
FGX INTERNATIONAL INC.
Model
10306635.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
00612409936080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612409936080006124099360806124099360800612409936080

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
00612409943996VERSANT VALUE10307362.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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08447504030140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030188ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030225ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030263ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030560ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030607ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030645ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030683ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030720ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030768ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030805ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030843ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030881ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033899ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033936ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033974ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034018ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034056ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034094ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034131ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034179ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034216ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034254ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034292ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034339ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034452ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034537ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22