FDA.reportPublic FDA data

LANTIS OPTICAL

Primary DI
00887661631411
Brand
LANTIS OPTICAL
Company
FGX INTERNATIONAL INC.
Model
10304236.INT
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
00887661631411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887661631411008876616314118876616314110887661631411

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
04066209026032FielmannFielmann Group AGHQZ2026-07-08
04066209033016FielmannFielmann Group AGHQZ2026-07-08
04066209033184FielmannFielmann Group AGHQZ2026-07-08
04066209040083FielmannFielmann Group AGHQZ2026-07-08
04066209044883FielmannFielmann Group AGHQZ2026-07-08
04066209046917FielmannFielmann Group AGHQZ2026-07-08
04066209046924FielmannFielmann Group AGHQZ2026-07-08
04066209047051FielmannFielmann Group AGHQZ2026-07-08
04066209049178FielmannFielmann Group AGHQZ2026-07-08
04066209051140FielmannFielmann Group AGHQZ2026-07-08
04066209051201FielmannFielmann Group AGHQZ2026-07-08
04066209052475FielmannFielmann Group AGHQZ2026-07-08
04066209052673FielmannFielmann Group AGHQZ2026-07-08
04066209052697FielmannFielmann Group AGHQZ2026-07-08
04066209052932FielmannFielmann Group AGHQZ2026-07-08
04066209055445FielmannFielmann Group AGHQZ2026-07-08
04066209055803FielmannFielmann Group AGHQZ2026-07-08
04066209056213FielmannFielmann Group AGHQZ2026-07-08
04066209058637FielmannFielmann Group AGHQZ2026-07-08
04066209058644FielmannFielmann Group AGHQZ2026-07-08
04066209058934FielmannFielmann Group AGHQZ2026-07-08
04066209059795FielmannFielmann Group AGHQZ2026-07-08
04066209060074FielmannFielmann Group AGHQZ2026-07-08
04066209060081FielmannFielmann Group AGHQZ2026-07-08
04066209060425FielmannFielmann Group AGHQZ2026-07-08
04066209060487FielmannFielmann Group AGHQZ2026-07-08
04066209060517FielmannFielmann Group AGHQZ2026-07-08
04066209063525FielmannFielmann Group AGHQZ2026-07-08
04066209063600FielmannFielmann Group AGHQZ2026-07-08
03701629014160Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-07