FDA.report

Blue Elephant

Primary DI
08800332260491
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
GOAT black
Published
2026-01-23
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

Related Records

Product Codes

CodeName
HQZFrame, Spectacle

Product Code Classifications

CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800332260491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800332260491088003322604918800332260491

GMDN Terms

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

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 DIBrandModelCatalogPublished
08800332268442Blue ElephantDRUKI leopard2026-01-29
08800332268459Blue ElephantDRUKI grey2026-01-29
08800332268466Blue ElephantDRUKI black2026-01-29
08800332268473Blue ElephantDRUKI ash brown2026-01-29
08800332268480Blue ElephantBANDI-S purple crystal2026-01-29
08800332268497Blue ElephantBANDI-S nude beige2026-01-29
08800332268503Blue ElephantBANDI-S leopard2026-01-29
08800332268510Blue ElephantBANDI-S black2026-01-29
08800332260293Blue ElephantYUKI brick2026-01-28
08800332260309Blue ElephantYUKI khaki 2026-01-28
08800332260613Blue ElephantSIGMA nude beige2026-01-28
08800332260972Blue ElephantSOL matte black2026-01-28
08800332260989Blue ElephantSOL matte silver2026-01-28
08800332261030Blue ElephantTIMMY ash brown2026-01-28
08800332261047Blue ElephantTIMMY brick2026-01-28
08800332261054Blue ElephantVIAN ash brown2026-01-28
08800332261061Blue ElephantVIAN black2026-01-28
08800332261078Blue ElephantVIAN brick2026-01-28
08800332261627Blue ElephantWILO black2026-01-28
08800332261634Blue ElephantWILO gold2026-01-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905498Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905504Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905511Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905528Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905535Zero G EyewearZero G EyewearHQZ2026-03-01
03701629014115Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014146Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
04066209005051FielmannFielmann Group AGHQZ2026-02-11
04066209005341FielmannFielmann Group AGHQZ2026-02-11
04066209005358FielmannFielmann Group AGHQZ2026-02-11
04066209005389FielmannFielmann Group AGHQZ2026-02-11
04066209006034FielmannFielmann Group AGHQZ2026-02-11
04066209006041FielmannFielmann Group AGHQZ2026-02-11
04066209006089FielmannFielmann Group AGHQZ2026-02-11
04066209008182FielmannFielmann Group AGHQZ2026-02-11
04066209008199FielmannFielmann Group AGHQZ2026-02-11
04066209008205FielmannFielmann Group AGHQZ2026-02-11
04066209008212FielmannFielmann Group AGHQZ2026-02-11
04066209008229FielmannFielmann Group AGHQZ2026-02-11
04066209008236FielmannFielmann Group AGHQZ2026-02-11
04066209009424FielmannFielmann Group AGHQZ2026-02-11
04066209019669FielmannFielmann Group AGHQZ2026-02-11
04066209019676FielmannFielmann Group AGHQZ2026-02-11
04066209019683FielmannFielmann Group AGHQZ2026-02-11
04066209019867FielmannFielmann Group AGHQZ2026-02-11
04066209019980FielmannFielmann Group AGHQZ2026-02-11