Duns Number:108179458
Device Description: microTargeting Insertion Tube with Stylet, 258.9mm
Catalog Number
66-IT-ME1P
Brand Name
microTargeting™ Insertion Tube
Version/Model Number
66-IT-ME1P-00858
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
K011775,K011775
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
2ba9e50a-ce42-46e3-83ca-22d16e37e3c1
Public Version Date
June 16, 2022
Public Version Number
1
DI Record Publish Date
June 08, 2022
Package DI Number
10873263008581
Quantity per Package
5
Contains DI Package
00873263008584
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK/5
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 |