Duns Number:217226935
Device Description: neuroinspire is a stereotactic software application intended to allow trained clinicians t neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures.
Catalog Number
-
Brand Name
neuroinspire
Version/Model Number
A-5630-3008
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
K163666,K163666
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
a355a502-2289-4acb-af1a-1b5f3063ae4a
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 2019
Package DI Number
15057078000021
Quantity per Package
1
Contains DI Package
05057078000024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-