Duns Number:108179458
Device Description: microTargeting™ MR Lead Insertion Tube 1 mm above target with Ceramic Stylet at target, no microTargeting™ MR Lead Insertion Tube 1 mm above target with Ceramic Stylet at target, non-sterile, 2x
Catalog Number
66-IT-MR3
Brand Name
microTargeting™ Insertion Tube
Version/Model Number
66-IT-MR3-00807
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K011775,K011775
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
d2ec7d65-777d-40c7-99b1-7d99656ef3a9
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 31, 2019
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 |