Duns Number:793169512
Device Description: ONSIGHT 3D EXTREMITY SYS W ATCH CONSOLE
Catalog Number
1743566
Brand Name
OnSight 3D Extremity System
Version/Model Number
OnSight 3D Extremity System
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
K160723
Product Code
JAK
Product Code Name
System, x-ray, tomography, computed
Public Device Record Key
39f7f276-e52e-40fe-b2ad-34d5c92e97af
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 19, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 328 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 688 |