FDA.reportPublic FDA data

Fast Metal

Primary DI
16972075360017
Brand
Fast Metal
Company
Minami Medical Technology (Guangdong) Co., Ltd.
Model
FMi32BKSMS1
Device description
sunglasse 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.
Published
2025-05-01
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

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
16972075360017PackageGS160In Commercial Distribution
06972075360010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697207536001716972075360017
06972075360010069720753600106972075360010

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
418188075
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972075360010Fast MetalFMi32BKSMS1 2025-05-01
06972075360027Fast MetalFMi32BKSMS1 2025-05-01
06972075360034Fast MetalFMi32BKSMS1 2025-05-01
16972075360024Fast MetalFMi32BKSMS1 2025-05-01
16972075360031Fast MetalFMi32BKSMS1 2025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158353SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158360SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158377SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158391SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158407SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158414SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158421SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158438SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158445SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158452SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158469SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158476SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158483SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158490SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158506SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158513SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158520SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158537SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158544SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158551SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158568SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158575SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158582SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158599SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158605SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158612SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158629SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158636SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
16973541158312SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
16973541158329SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24