FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348923434
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
MARINA leopard
Published
2026-08-14
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
08800348923434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348923434088003489234348800348923434

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
08800348923403Blue ElephantDUNGA-S black2026-08-14
08800348923410Blue ElephantDUNGA-S black crystal2026-08-14
08800348923427Blue ElephantDUNGA-S leopard2026-08-14
08800348923441Blue ElephantMARINA-S leopard2026-08-14
08800348923458Blue ElephantMINCO grey crystal2026-08-14
08800348923465Blue ElephantNANIA purple crystal2026-08-14
08800348923472Blue ElephantTAKI black2026-08-14
08800348923489Blue ElephantTAKI leopard2026-08-14
08800348923496Blue ElephantTAKI-S grey crystal2026-08-14
08800348923502Blue ElephantTAKI-S khaki2026-08-14
08800348923519Blue ElephantTAKI-S leopard2026-08-14
08800332261580Blue ElephantVIGOR black2026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08447504028307ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028345ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028383ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028420ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029342ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029380ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029427ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029465ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031529ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031567ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031604ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031642ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032007ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032045ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032083ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032120ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032168ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032205ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032243ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032281ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035251ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036777ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036814ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036852ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036890ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037897ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037934ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26