Duns Number:611195173
Device Description: SL PREMIUM STYLE-B W/AR- Frame Material: Stainless Steel - Rimless StimuLight® Amber Non- SL PREMIUM STYLE-B W/AR- Frame Material: Stainless Steel - Rimless StimuLight® Amber Non-Polarized Anti-Reflective Low Light Glasses
Catalog Number
41501
Brand Name
Eagle Eyes
Version/Model Number
41501
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQY
Product Code Name
Sunglasses (Non-Prescription Including Photosensitive)
Public Device Record Key
c9028100-eabd-4d87-8846-8accb251d813
Public Version Date
August 09, 2021
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 245 |