FDA.reportPublic FDA data

Green Sprouts

Primary DI
00715418155357
Brand
Green Sprouts
Company
O2cool, LLC
Model
758391-602-01
Device description
Flexible Sunglasses-Aqua-0/24mo
Published
2021-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00715418155357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00715418155357007154181553577154181553570715418155357

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
004603413
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00715418071640Green Sprouts379300-300-002021-06-01
00715418071657Green Sprouts379300-500-002021-06-01
00715418088563Green Sprouts379300-201-002021-06-01
00715418094045Green Sprouts379300-916-002021-06-01
00715418020358Green Sprouts222341-920-332223412016-08-23
00715418028590Green Sprouts222340-287-332017-04-12
00715418091136Green Sprouts222392-905-332223922016-09-15
00715418091143Green Sprouts222392-906-332223922016-09-15
00715418046464Green Sprouts309302-523-222021-06-01
00715418077291Green Sprouts242342-907-332021-06-01
00715418092843Green Sprouts22391-907-332021-06-01
00715418093314Green Sprouts222392-920-332021-06-01
00715418127620Green Sprouts264305-907-342021-06-01
00715418128023Green Sprouts221040-920-342021-06-01
00715418130095Green Sprouts221040-575-342021-06-01
00715418130101Green Sprouts221040-676-342021-06-01
00715418130118Green Sprouts221040-274-342021-06-01
00715418147208Green Sprouts385301-400-332021-06-01
00715418154688Green Sprouts385632-001-332021-06-01
00715418155333Green Sprouts758391-000-012021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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