FDA.reportPublic FDA data

Randolph

Primary DI
00044409916227
Brand
Randolph
Company
Randolph Engineering, Inc.
Model
AF005
Catalog number
NA
Device description
SUN,AVIATOR,52MM,23K GOLD E.P.,BAYONET 140,SKYTEC™ AMERICAN GRAY
Published
2022-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00044409916227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00044409916227000444099162270444099162270044409916227

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065152217
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800332263010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263041Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263584Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263614Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264765Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264772Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264789Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264796Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332269968Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332269975Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
04582647307972MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307989MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307996MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308146MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308153MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308160MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308313MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308320MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308375MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308382MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308399MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308405MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308412MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308429MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308436MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308443MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308450MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308467MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308559MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308566MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30