Duns Number:241987692
Device Description: Disposable Reflective Spheres attached to reference frames and surgical instruments for us Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There is 1 tray-in-pouch for a total of 5 spheres.
Catalog Number
8801085
Brand Name
NDI Passive Sphere
Version/Model Number
8801085
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
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
K033621
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
48a80d06-dfdf-4e76-b99b-01043254c9e7
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 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. | 14 |