FDA UDI
In Commercial Distribution
🇺🇸 United States
Fast Metal
DI: 06972075360034
·
Model: FMi32BKSMS1
·
Minami Medical Technology (Guangdong) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Fast Metal
- Primary DI
- 06972075360034
- Version / Model
- FMi32BKSMS1
- Company Name
- Minami Medical Technology (Guangdong) Co., Ltd.
- Labeler DUNS
- 418188075
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-01
- Public Version
- 1
- Public Version Date
- 2025-05-09
- Public Version Status
- New
- Public Device Record Key
- d43e48a3-f8b1-42ae-9b97-55bcaae41e16
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | 886.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 39694 | Tinted non-prescription spectacles | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16972075360031 | GS1 | box | 60 | In Commercial Distribution | |
| Primary | 06972075360034 | GS1 |