Model: SLEN peach
DI: 08800332268916
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
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:
6a1c9a2a-829d-4160-a042-9b1235b0e53a
Distribution Status:
In Commercial Distribution
DUNS Number:
695736511
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:
No
Identifiers
Device ID:
08800332268916
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
HQY
Sunglasses (Non-Prescription Including Photosensitive)