FDA.report

Zac Posen

Primary DI
00715317216784
Brand
Zac Posen
Company
Kenmark Optical, Inc.
Model
ZRHENV50
Device description
Rhett Navy Horn Spectacle
Published
2021-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00715317216784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00715317216784007153172167847153172167840715317216784

GMDN Terms

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

Contacts

PhoneEmail
+1(502)267-4486gudid@kenmarkeyewear.com

Regulatory Flags

DUNS number
062952593
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

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