FDA.reportPublic FDA data

Kensie

Primary DI
00715317017404
Brand
Kensie
Company
Kenmark Optical, Inc.
Model
HAUTNV49
Device description
Haute Navy Spectacle
Published
2021-07-28
Public version status
Update
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
00715317017404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00715317017404007153170174047153170174040715317017404

GMDN Terms#

Term, Definition table
TermDefinition
Vision corrective 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
08435736028646ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736028721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090698ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090759ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504042976ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043010ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043058ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043096ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736088213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088275ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088398ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088596ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088794ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088916ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089036ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089098ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089159ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090810ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090872ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090933ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090995ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091114ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18