FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800332261580
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
VIGOR black
Published
2026-07-31
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

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
08800332261580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800332261580088003322615808800332261580

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
695736511
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800332261597Blue ElephantVIGOR deep brown2026-07-31
08800332261603Blue ElephantVIGOR leopard2026-07-31
08800332261610Blue ElephantVIGOR nude beige2026-07-31
08800332263010Blue ElephantRINOX grey crystal2026-07-31
08800332263041Blue ElephantRINOX purple2026-07-31
08800332263584Blue ElephantVILLA ash brown2026-07-31
08800332263614Blue ElephantVILLA leopard2026-07-31
08800332264765Blue ElephantFOSSE black2026-07-31
08800332264772Blue ElephantFOSSE deep brown2026-07-31
08800332264789Blue ElephantFOSSE leopard2026-07-31
08800332264796Blue ElephantFOSSE red wine2026-07-31
08800332269968Blue ElephantRINOX red wine2026-07-31
08800332269975Blue ElephantRINOX leopard (N)2026-07-31
08800348920907Blue ElephantBLAIR black2026-07-22
08800348920914Blue ElephantBLAIR green2026-07-22
08800348920921Blue ElephantBLAIR leopard2026-07-22
08800348920938Blue ElephantBLAIR plum2026-07-22
08800348920945Blue ElephantFONI black2026-07-22
08800348920952Blue ElephantFONI leopard2026-07-22
08800348920969Blue ElephantFONI pearl pink2026-07-22

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