FDA.reportPublic FDA data

Entourage of 7

Primary DI
05712544173137
Brand
Entourage of 7
Company
Bellinger A/S
Model
HADLEY-SK-1090
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

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
05712544173137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712544173137057125441731375712544173137

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
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
05712544173267BellingerSTRATOS-7412026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435736087377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736087414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736087490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088091ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088138ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098311ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098359ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098397ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098434ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002734ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002772ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002819ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002857ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504026020ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504027140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736092616ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092654ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092692ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092739ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097833ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097871ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097918ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097956ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000617ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000693ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000730ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504025702ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504025740ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02