Model: MK22 OVERRIDE
DI: 06979132461512
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-28
Current Version: 2026-05-06
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1b01a036-5bf4-4476-af8a-ba7493b2ea7e
Distribution Status:
In Commercial Distribution
DUNS Number:
976389484
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06979132461512
Type:
Primary
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
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat