FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800332260880
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
JERRI grey crystal
Published
2026-01-26
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
08800332260880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800332260880088003322608808800332260880

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
695736511
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800348920242Blue ElephantKELLY black2026-06-25
08800348920259Blue ElephantKELLY crystal2026-06-25
08800348920266Blue ElephantROTO black2026-06-25
08800348920273Blue ElephantROTO leopard2026-06-25
08800348920280Blue ElephantCAMI black2026-06-25
08800348920297Blue ElephantCAMI deep brown2026-06-25
08800348920303Blue ElephantCAMI grey crystal2026-06-25
08800348920310Blue ElephantCAMI leopard2026-06-25
08800348920327Blue ElephantKELLY-S black2026-06-25
08800348920334Blue ElephantKELLY-S brick crystal2026-06-25
08800348920341Blue ElephantKELLY-S grey2026-06-25
08800348920358Blue ElephantKELLY-S leopard2026-06-25
08800348920365Blue ElephantMODIQ black2026-06-25
08800348920372Blue ElephantMODIQ grey2026-06-25
08800348920389Blue ElephantMODIQ khaki2026-06-25
08800348920396Blue ElephantMODIQ leopard2026-06-25
08800348920402Blue ElephantROTO-S black2026-06-25
08800348920419Blue ElephantROTO-S brown2026-06-25
08800348920426Blue ElephantVIERA black2026-06-25
08800348920433Blue ElephantVIERA brown2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10
04580822704288EYEVANEYEVAN INC.HQZ2026-07-10
04580822704295EYEVANEYEVAN INC.HQZ2026-07-10
04580822704561EYEVANEYEVAN INC.HQZ2026-07-10
04580822704578EYEVANEYEVAN INC.HQZ2026-07-10
04580822704585EYEVANEYEVAN INC.HQZ2026-07-10
04580822704592EYEVANEYEVAN INC.HQZ2026-07-10
04580822704837EYEVANEYEVAN INC.HQZ2026-07-10
04580822704844EYEVANEYEVAN INC.HQZ2026-07-10
04580822704851EYEVANEYEVAN INC.HQZ2026-07-10
04580822704868EYEVANEYEVAN INC.HQZ2026-07-10
04580822704998EYEVANEYEVAN INC.HQZ2026-07-10
04580822705018EYEVANEYEVAN INC.HQZ2026-07-10
04580822705025EYEVANEYEVAN INC.HQZ2026-07-10
04580822705049EYEVANEYEVAN INC.HQZ2026-07-10
04582669065393EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065409EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065416EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065454EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065461EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10