Duns Number:079375431
Device Description: Game Ready Every Athlete Program, Gold Package
Catalog Number
552724
Brand Name
Game Ready
Version/Model Number
552724
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192114
Product Code
ILO
Product Code Name
Pack, hot or cold, water circulating
Public Device Record Key
6bc300e7-711b-4773-b125-5f0b1af69dad
Public Version Date
April 15, 2021
Public Version Number
1
DI Record Publish Date
April 07, 2021
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 | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |