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
08435736028646ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736028721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090698ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090759ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504042976ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043010ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043058ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043096ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736088213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088275ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088398ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088596ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088794ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088916ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089036ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089098ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089159ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090810ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090872ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090933ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090995ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091114ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18