Duns Number:177953189
Device Description: 52-19-140 NAVY COLOURS BY ALEXANDER JULIAN
Catalog Number
-
Brand Name
EYEWEAR BY ROI SEGOVIA NAVY
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2022
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQZ
Product Code Name
Frame, spectacle
Public Device Record Key
cb68fe78-9f24-4e65-8ab2-678b82729de7
Public Version Date
October 17, 2022
Public Version Number
2
DI Record Publish Date
July 08, 2022
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 | 1324 |