FDA.reportPublic FDA data

b.color

Primary DI
00049696188371
Brand
b.color
Company
FOURSTAR GROUP INC.
Model
64409558SB
Device description
SUNGLASSES
Published
2023-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00049696188371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00049696188371000496961883710496961883710049696188371

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
656091279
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00049696561228THERA Plus644103222026-06-09
00049696189583THERA Plus644101842026-06-09
00049696198189B.PURE644103382026-06-09
00049696295260THERA Plus644103662026-06-09
00049696295277THERA Plus644103662026-06-09
00049696295284THERA Plus644103662026-06-09
00049696295291THERA Plus644103662026-06-09
00049696295307THERA Plus644103662026-06-09
00049696295314THERA Plus644103662026-06-09
00049696508339THERA Plus64409658V2026-06-09
00049696508346B.PURE64409346B2026-06-09
00049696508360THERA Plus64409535A2026-06-09
00049696508377THERA Plus64409535B2026-06-09
00049696508384THERA Plus64409535C2026-06-09
00049696561518B.PURE644103252026-06-09
00049696562102B.PURE644103262026-06-09
00049696677547THERA Plus644103832026-06-09
00049696712194B.PURE644102892026-06-09
00049696898232B.PURE64410005D2026-06-09
00050428284537CVSHealth64408659Y2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580822704165EYEVANEYEVAN INC.HQY2026-07-10
04580822704172EYEVANEYEVAN INC.HQY2026-07-10
04580822704189EYEVANEYEVAN INC.HQY2026-07-10
04580822704196EYEVANEYEVAN INC.HQY2026-07-10
04580822704660EYEVANEYEVAN INC.HQY2026-07-10
04580822704677EYEVANEYEVAN INC.HQY2026-07-10
04580822704684EYEVANEYEVAN INC.HQY2026-07-10
04580822704691EYEVANEYEVAN INC.HQY2026-07-10
04580822704707EYEVANEYEVAN INC.HQY2026-07-10
04580822705148EYEVANEYEVAN INC.HQY2026-07-10
04580822705155EYEVANEYEVAN INC.HQY2026-07-10
04580822705162EYEVANEYEVAN INC.HQY2026-07-10
04580822705179EYEVANEYEVAN INC.HQY2026-07-10
04580822705186EYEVANEYEVAN INC.HQY2026-07-10
04580822705193EYEVANEYEVAN INC.HQY2026-07-10
04580822705223EYEVANEYEVAN INC.HQY2026-07-10
04580822705230EYEVANEYEVAN INC.HQY2026-07-10
04582669067885E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067892E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067908E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067915E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067922E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068417E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068424E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068455E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068462E5 eyevanEYEVAN INC.HQY2026-07-10
04582669069384EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069391EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069407EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069582EYEVAN7285EYEVAN INC.HQY2026-07-10