DEVICE: ASSORTED BRANDS (00193033366905)
Device Identifier (DI) Information
ASSORTED BRANDS
DL5371/106.FDR
In Commercial Distribution
FGX INTERNATIONAL INC.
DL5371/106.FDR
In Commercial Distribution
FGX INTERNATIONAL INC.
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HQY | Sunglasses (non-prescription including photosensitive) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
42c67191-8413-42b2-8f9f-97088f41de54
June 30, 2022
1
June 22, 2022
June 30, 2022
1
June 22, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(401)231-3800
Customerservices@fgxi.com
Customerservices@fgxi.com