Duns Number:847029543
Device Description: Spectacle Frame, Size 52-15-135
Catalog Number
XOCARACASBECH0OPT
Brand Name
XOXO
Version/Model Number
XO Caracas Blue Cheetah
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
HQR
Product Code Name
Apparatus, cautery, radiofrequency, ac-powered
Public Device Record Key
4da69650-4f53-4c54-b532-d2ebbe6d3143
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
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 | 232 |
2 | A medical device with a moderate to high risk that requires special controls. | 1353 |