FDA.report

Entourage of 7

Primary DI
05712544174271
Brand
Entourage of 7
Company
Bellinger A/S
Model
PALM-VIPER-4-1056
Device description
Spectacle frame
Published
2026-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQZFrame, Spectacle

Product Code Classifications

CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05712544174271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05712544174271057125441742715712544174271

GMDN Terms

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

Regulatory Flags

DUNS number
310327304
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
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
04066209019980FielmannFielmann Group AGHQZ2026-02-11