FDA.reportPublic FDA data

Timex

Primary DI
00715317207836
Brand
Timex
Company
Kenmark Optical, Inc.
Model
226PBR60
Device description
2:26 Pm Brown Spectacle
Published
2021-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00715317207836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00715317207836007153172078367153172078360715317207836

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(502)267-4486gudid@kenmarkeyewear.com

Regulatory Flags#

DUNS number
062952593
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00715317000604Vera WangSRYABK522021-08-27
00715317000611Vera WangSRYAHN522021-08-27
00715317002912Vera WangSRYANV522021-08-27
00715317016056Vera WangCHIABK582021-08-27
00715317016063Vera WangCHIANV582021-08-27
00715317016070Vera WangCHIABR582021-08-27
00715317016087Vera WangCHIARD582021-08-27
00715317016155Vera WangPTLNBK572021-08-27
00715317016162Vera WangPTLNYG572021-08-27
00715317016230Vera WangPRSTBK522021-08-27
00715317016247Vera WangPRSTBL522021-08-27
00715317016254Vera WangPRSTBR522021-08-27
00715317019095Zac PosenZRITJD562021-08-27
00715317021173Zac PosenZHAYBK552021-08-27
00715317021180Zac PosenZHAYBR552021-08-27
00715317021197Zac PosenZHAYTO552021-08-27
00715317023573Vera WangSKYLBK542021-08-27
00715317023580Vera WangSKYLBE542021-08-27
00715317023597Vera WangSKYLTE542021-08-27
00715317035248KensieCLBTOL512021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30