Duns Number:062312087
Catalog Number
-
Brand Name
REEBOK
Version/Model Number
10225234.QTM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 20, 2023
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
HQY
Product Code Name
Sunglasses (non-prescription including photosensitive)
Public Device Record Key
92b429c6-0985-4021-84ad-51eef7c9fa1f
Public Version Date
October 27, 2022
Public Version Number
2
DI Record Publish Date
June 28, 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 | 74463 |