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 10 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 20 spheres.
Catalog Number
8801320
Brand Name
NDI Passive Spheres
Version/Model Number
8801320
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,K033621
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
4bb2e1af-d11b-4993-a0d2-7bd4855511c6
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20805832030041
Quantity per Package
2
Contains DI Package
00805832030047
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tray in Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |