FDA.reportPublic FDA data

Kensie

Primary DI
00715317195270
Brand
Kensie
Company
Kenmark Optical, Inc.
Model
EDGYPU51
Device description
Edgy Purple 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
00715317195270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00715317195270007153171952707153171952700715317195270

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
08447504030140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030188ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030225ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030263ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030560ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030607ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030645ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030683ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030720ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030768ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030805ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030843ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030881ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033899ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033936ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033974ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034018ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034056ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034094ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034131ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034179ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034216ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034254ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034292ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034339ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034452ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034537ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22