FDA.reportPublic FDA data

VERSANT BONGO

Primary DI
00715583136557
Brand
VERSANT BONGO
Company
FGX INTERNATIONAL INC.
Model
10307552.VER
Published
2022-06-22
Public version status
New
Distribution status
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
00715583136557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00715583136557007155831365577155831365570715583136557

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
08435736091299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091374ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091411ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091459ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091497ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091572ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091619ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091657ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091695ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091770ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091817ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091893ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091930ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736092012ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736092050ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002178ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002215ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002253ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002291ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002338ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002376ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002413ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002451ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002499ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002574ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08