FDA.reportPublic FDA data

BBIG

Primary DI
08719616000091
Brand
BBIG
Company
BBig B.V.
Model
0014399
Device description
0014399
Published
2017-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
08719616000091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719616000091087196160000918719616000091

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).

Regulatory Flags#

DUNS number
408104979
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719616000008BBIG001411012017-10-15
08719616000015BBIG001411072017-10-15
08719616000022BBIG00141762017-10-15
08719616000039BBIG00141932017-10-15
08719616000046BBIG00141992017-10-15
08719616000053BBIG001431012017-10-15
08719616000060BBIG001431072017-10-15
08719616000077BBIG00143762017-10-15
08719616000084BBIG00143932017-10-15
08719616000107BBIG004421002017-10-15
08719616001098BBIG014412112017-10-15
08719616001104BBIG014415402017-10-15
08719616001111BBIG01441952017-10-15
08719616001128BBIG015391702017-10-15
08719616001135BBIG015391772017-10-15
08719616001142BBIG015395402017-10-15
08719616001159BBIG01539802017-10-15
08719616001166BBIG01539902017-10-15
08719616001173BBIG01539922017-10-15
08719616001180BBIG01539932017-10-15

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