FDA.reportPublic FDA data

Bellinger

Primary DI
05712544166986
Brand
Bellinger
Company
Bellinger A/S
Model
BLAZE-2-4514
Device description
Spectacle frame
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05712544166986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712544166986057125441669865712544166986

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
310327304
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712544171188Entourage of 7BAXTER-02242026-02-11
05712544171195BellingerJUST-437-6832026-02-11
05712544171546BellingerJUST-SERENE-1262026-02-11
05712544171553BellingerJUST-SERENE-2192026-02-11
05712544173106Entourage of 7HADLEY-SK-02272026-02-11
05712544173113Entourage of 7HADLEY-SK-04472026-02-11
05712544173120Entourage of 7HADLEY-SK-08452026-02-11
05712544173137Entourage of 7HADLEY-SK-10902026-02-11
05712544173144Entourage of 7FIELD-08472026-02-11
05712544173151Entourage of 7FIELD-10562026-02-11
05712544173168Entourage of 7FIELD-04492026-02-11
05712544173175Entourage of 7FIELD-05422026-02-11
05712544173182Entourage of 7THEODORE-08382026-02-11
05712544173199Entourage of 7THEODORE-10562026-02-11
05712544173205Entourage of 7THEODORE-04032026-02-11
05712544173212Entourage of 7THEODORE-02412026-02-11
05712544173229Entourage of 7ARTURO-05582026-02-11
05712544173236Entourage of 7ARTURO-01212026-02-11
05712544173243Entourage of 7ARTURO-02432026-02-11
05712544173250Entourage of 7ARTURO-10072026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800332269944Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-05-22
00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905498Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905504Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905511Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905528Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905535Zero G EyewearZero G EyewearHQZ2026-03-01
03701629014115Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014146Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
04066209005051FielmannFielmann Group AGHQZ2026-02-11
04066209005341FielmannFielmann Group AGHQZ2026-02-11
04066209005358FielmannFielmann Group AGHQZ2026-02-11
04066209005389FielmannFielmann Group AGHQZ2026-02-11
04066209006034FielmannFielmann Group AGHQZ2026-02-11
04066209006041FielmannFielmann Group AGHQZ2026-02-11
04066209006089FielmannFielmann Group AGHQZ2026-02-11
04066209008182FielmannFielmann Group AGHQZ2026-02-11
04066209008199FielmannFielmann Group AGHQZ2026-02-11
04066209008205FielmannFielmann Group AGHQZ2026-02-11
04066209008212FielmannFielmann Group AGHQZ2026-02-11
04066209008229FielmannFielmann Group AGHQZ2026-02-11
04066209008236FielmannFielmann Group AGHQZ2026-02-11
04066209009424FielmannFielmann Group AGHQZ2026-02-11
04066209019669FielmannFielmann Group AGHQZ2026-02-11
04066209019676FielmannFielmann Group AGHQZ2026-02-11
04066209019683FielmannFielmann Group AGHQZ2026-02-11
04066209019867FielmannFielmann Group AGHQZ2026-02-11