FDA.report

AYA Optical

Primary DI
00628120770933
Brand
AYA Optical
Company
Claudia Alan Inc
Model
AYO0884GRN
Device description
Ashley - 0884 - Green
Published
2023-12-11
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
00628120770933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00628120770933006281207709336281207709330628120770933

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
241994500
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
00628120774719AYA OpticalAYO0423BLS2025-05-05
00628120774726AYA OpticalAYO0423CHG2025-05-05
00628120774733AYA OpticalAYO0424BRN2025-05-05
00628120774740AYA OpticalAYO0424BLK2025-05-05
00628120774382AYA OpticalAYO0419TEA2024-12-20
00628120774399AYA OpticalAYO0419XLTEA2024-12-20
00628120774405AYA OpticalAYO0419BRG2024-12-20
00628120774412AYA OpticalAYO0419XLBRG2024-12-20
00628120774429AYA OpticalAYO0420CML2024-12-20
00628120774436AYA OpticalAYO0421BRN2024-12-20
00628120774443AYA OpticalAYO0420GRY2024-12-20
00628120774450AYA OpticalAYO0421CCL2024-12-20
00628120774467AYA OpticalAYO0422BLK2024-12-20
00628120774474AYA OpticalAYO0422BRN2024-12-20
00628120774481AYA OpticalAYO0827PBR2024-12-20
00628120774498AYA OpticalAYO0827BLU2024-12-20
00628120774504AYA OpticalAYO0827GRN2024-12-20
00628120774702AYA OpticalAYO0884SGB2024-11-02
00628120774221AYA OpticalAYS0160HAV2024-10-09
00628120774238AYA OpticalAYS0160GRY2024-10-09

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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
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03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
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04066209005341FielmannFielmann Group AGHQZ2026-02-11
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