Duns Number:108179458
Device Description: NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medt NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation Systems
Catalog Number
NP-1000
Brand Name
Nexprobe®
Version/Model Number
NP-1000-00770
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K040334
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
8e4e7785-ddda-41c8-9e89-f17f921ca610
Public Version Date
November 13, 2020
Public Version Number
1
DI Record Publish Date
November 05, 2020
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |