FDA.reportPublic FDA data

Monsieur Pierre

Primary DI
03701629009166
Brand
Monsieur Pierre
Company
NEW INTERNATIONAL VISION
Model
MALCOM Rose-Violine
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
03701629009166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701629009166037016290091663701629009166

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

Regulatory Flags#

DUNS number
277124322
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701629015006Pierre EyewearZIPHA-T45 CA282026-07-21
03701629014160Pierre EyewearVEGA Cream2026-07-07
03701629014177Pierre EyewearVEGA Cardinal2026-07-07
03701629014184Pierre EyewearSIMONE Taupe2026-07-07
03701629014191Pierre EyewearSIMONE Saumon2026-07-07
03701629014207Pierre EyewearSIMONE Ecaille Orange2026-07-07
03701629014214Pierre EyewearSIMONE Ecaile Kaki2026-07-07
03701629014221Pierre EyewearQUEEN Orange SUN2026-07-07
03701629014238Pierre EyewearQUEEN Ecaille Vert SUN2026-07-07
03701629014245Pierre EyewearQUEEN Coconut SUN2026-07-07
03701629014252Pierre EyewearQUEEN Blk & Red SUN2026-07-07
03701629014269Pierre EyewearQUEEN Blk & Red2026-07-07
03701629014276Pierre EyewearPIAF Rosa SUN2026-07-07
03701629014283Pierre EyewearONE LOVE Noir2026-07-07
03701629014290Pierre EyewearONE LOVE Ecaille Taupe2026-07-07
03701629014306Pierre EyewearONE LOVE Ecaille Rouge2026-07-07
03701629014313Pierre EyewearONE LOVE Bordeaux Roi2026-07-07
03701629014320Pierre EyewearLYRA Cream2026-07-07
03701629014337Pierre EyewearLYRA Cardinal2026-07-07
03701629014344Pierre EyewearLOU Marron2026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348921041Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921058Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921096Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921102Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
03701629015006Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-21
08800348920501Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920518Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920587Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920594Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920600Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920617Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920662Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920679Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920716Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920723Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920730Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920778Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920785Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920860Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10