Model: 4000 GRA
DI: 08908016666772
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Sunglass Black Frame/Gray Temple
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6b50d09e-51f7-4e75-a2a7-325a1da50a1c
Distribution Status:
In Commercial Distribution
DUNS Number:
771460561
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
08904527200320
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
300
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08908016666772
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08908016666772
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 39694
Name: Tinted non-prescription spectacles
Definition:
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.
FDA Product Codes
HQY
Sunglasses (Non-Prescription Including Photosensitive)