Duns Number:340306351
Device Description: Treatment Center INTEGO pro CS ambidextrous with water bottle
Catalog Number
-
Brand Name
INTEGO pro CS ambidextrous
Version/Model Number
6591882
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
EBW
Product Code Name
Controller, Foot, Handpiece And Cord
Public Device Record Key
be33e528-b8a3-486a-893b-c1ba70b16de2
Public Version Date
May 17, 2022
Public Version Number
5
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 235 |
2 | A medical device with a moderate to high risk that requires special controls. | 326 |