FDA.reportPublic FDA data

E5 eyevan

Primary DI
04582669059866
Brand
E5 eyevan
Company
EYEVAN INC.
Model
P25E 49 DNM
Published
2025-11-15
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
04582669059866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582669059866045826690598664582669059866

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
705184505
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580822703694EYEVANFOUNTAIN 50 AG2026-07-10
04580822703724EYEVANFOUNTAIN 50 RG2026-07-10
04580822703731EYEVANFOUNTAIN 50 S2026-07-10
04580822703748EYEVANFOUNTAIN 50 YG2026-07-10
04580822704165EYEVANMATEO-E 53 MPBK-D.MST.FADE2026-07-10
04580822704172EYEVANMATEO-E 53 PBKS-MD.GY2026-07-10
04580822704189EYEVANMATEO-E 53 PBKG-S.BR2026-07-10
04580822704196EYEVANMATEO-E 53 TORT-GRY2026-07-10
04580822704264EYEVANWEBB SQ(49)-E 49 BKWHN2026-07-10
04580822704271EYEVANWEBB SQ(49)-E 49 ECR2026-07-10
04580822704288EYEVANWEBB SQ(49)-E 49 GPT2026-07-10
04580822704295EYEVANWEBB SQ(49)-E 49 TORT2026-07-10
04580822704561EYEVANSUNSET-E 57 BGN2026-07-10
04580822704578EYEVANSUNSET-E 57 LSMK2026-07-10
04580822704585EYEVANSUNSET-E 57 PBKS2026-07-10
04580822704592EYEVANSUNSET-E 57 TORT2026-07-10
04580822704660EYEVANSUNSET-E 57 BGN-GRY2026-07-10
04580822704677EYEVANSUNSET-E 57 CRL-P.BLUH2026-07-10
04580822704684EYEVANSUNSET-E 57 LLT-D.MST.FADE2026-07-10
04580822704691EYEVANSUNSET-E 57 LSMK-GY.GRD22026-07-10

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