FDA.report

Sperry

Primary DI
00730638344817
Brand
Sperry
Company
L'Amy, Incorporated
Model
SPKATHERINE03
Device description
SUNGLASSES -SPKATHERINE C03 TEAL TORT/NAVY 53-17137C
Published
2022-12-01
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

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
00730638344817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00730638344817007306383448177306383448170730638344817

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00730638343612ChampionCU6001H012022-12-02
00730638343629ChampionCU6001H022022-12-02
00730638343636ChampionCU6001H032022-12-02
00730638343643ChampionCU6002H012022-12-02
00730638343650ChampionCU6002H022022-12-02
00730638343667ChampionCU6002H032022-12-02
00730638343674ChampionCU6003H012022-12-02
00730638343681ChampionCU6003H022022-12-02
00730638343698ChampionCU6003H032022-12-02
00730638346019Ann TaylorTYATP909012022-12-02
00730638346026Ann TaylorTYATP909022022-12-02
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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