Duns Number:078450878
Device Description: Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M9377103 Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.
Catalog Number
71034601
Brand Name
EXOGEN® Ultrasound Bone Healing System
Version/Model Number
71034601
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
Yes
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
P900009
Product Code
LOF
Product Code Name
Stimulator, Bone Growth, Non-Invasive
Public Device Record Key
0874bc09-a46e-43b0-bdc2-33d599bc1469
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 12, 2017
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. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 5 |