FDA.report

McLaren

Primary DI
00730638423239
Brand
McLaren
Company
L'Amy, Incorporated
Model
MLDS-89S0301
Device description
SUNGLASSES -MLDS-89S03 C01 BLACK/BLACK 54-17 145F
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00730638423239PrimaryGS10

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
2037610611support@lamyamerica.com

Regulatory Flags

DUNS number
101332278
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

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00730638346033Ann TaylorTYATP909032022-12-02
00730638346071Ann TaylorTYATP910012022-12-02
00730638346088Ann TaylorTYATP910022022-12-02
00730638346095Ann TaylorTYATP910032022-12-02
00730638347207Ann TaylorTYATP911022022-12-02
00730638347214Ann TaylorTYATP911032022-12-02
00730638347221Ann TaylorTYATP912012022-12-02
00730638347245Ann TaylorTYATP912032022-12-02
00730638350252SperrySPSTRIPER012022-12-02

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