Duns Number:847990566
Device Description: Wrap, Large, Pink Camo
Catalog Number
-
Brand Name
inCourage®
Version/Model Number
137022-007
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
K051383
Product Code
BYI
Product Code Name
Percussor, Powered-Electric
Public Device Record Key
4bd93712-a7a6-4ee1-b808-843ef050bb80
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
September 10, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 271 |