FDA.report

Sweet Protection

Primary DI
B910852052070000OS0
Brand
Sweet Protection
Company
ACTIVE BRANDS NORTH AMERICA INC
Model
852052070000OS
Published
2021-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
B910852052070000OS0PrimaryHIBCC0

GMDN Terms

TermDefinition
Tinted spectacle lens, non-prescriptionAn ophthalmic device made of a treated glass or plastic that is used to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light, but not to provide refractive corrections. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods

Method

Contacts

PhoneEmail
7205854446dan.kurtz@activebrands.com

Regulatory Flags

DUNS number
079818658
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
B910810104010000OS0Sweet Protection810104010000OS2021-01-12
B910810105010000OS0Sweet Protection810105010000OS2021-01-12
B910852031160400OS0Sweet Protection852031160400OS2021-01-12
B910852031167400OS0Sweet Protection852031167400OS2021-01-12
B910852031191300OS0Sweet Protection852031191300OS2021-01-12
B910852031200500OS0Sweet Protection852031200500OS2021-01-12
B910852043061200OS0Sweet Protection852043061200OS2021-01-12
B910852043076300OS0Sweet Protection852043076300OS2021-01-12
B910852043152000OS0Sweet Protection852043152000OS2021-01-12
B910852043160400OS0Sweet Protection852043160400OS2021-01-12
B910852043220400OS0Sweet Protection852043220400OS2021-01-12
B910852043221200OS0Sweet Protection852043221200OS2021-01-12
B910852044220100OS0Sweet Protection852044220100OS2021-01-12
B910852044220400OS0Sweet Protection852044220400OS2021-01-12
B910852044221200OS0Sweet Protection852044221200OS2021-01-12
B910852046061200OS0Sweet Protection852046061200OS2021-01-12
B910852046076300OS0Sweet Protection852046076300OS2021-01-12
B910852046152000OS0Sweet Protection852046152000OS2021-01-12
B910852046160400OS0Sweet Protection852046160400OS2021-01-12
B910852047220100OS0Sweet Protection852047220100OS2021-01-12

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