FDA.report

EYEVAN7285

Primary DI
04571445038928
Brand
EYEVAN7285
Company
EYEVAN INC.
Model
329 49 301
Published
2022-09-09
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
04571445038928PrimaryGS10

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
705184505
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

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04582669058142EYEVANLIVINGSTON(49)-E 49 SMK-S.BR2025-12-10
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04582669053345EYEVANARETHA-E 49 PGPK2025-11-15
04582669053352EYEVANARETHA-E 49 AQBL2025-11-15
04582669053369EYEVANARETHA-E 49 BGN2025-11-15
04582669053376EYEVANSULLIVAN-E 50 BGN2025-11-15
04582669053383EYEVANSULLIVAN-E 50 IDG2025-11-15
04582669053390EYEVANSULLIVAN-E 50 YT2025-11-15
04582669053406EYEVANSULLIVAN-E 50 MPBK2025-11-15
04582669053413EYEVANSULLIVAN-E 50 PGPK2025-11-15
04582669053420EYEVANSULLIVAN-E 50 SLGRY2025-11-15
04582669054359EYEVANARETHA-E 49 SPA2025-11-15
04582669054526EYEVAN7285717E-TR 46 2030-BK2025-11-15
04582669054533EYEVAN7285717E-TR 46 3320-BR2025-11-15
04582669054540EYEVAN7285717E-TR 46 112802-BK2025-11-15
04582669054557EYEVAN7285717E-TR 46 345805-BLU2025-11-15
04582669054564EYEVAN7285762-TR2 48 3013-GRN2025-11-15
04582669054571EYEVAN7285762-TR2 48 4071-BK2025-11-15

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00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
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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
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03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014146Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
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