Duns Number:108179458
Device Description: microTargeting Single Insertion Tube with Stylet, Sterile, at target, for use with Nexfram microTargeting Single Insertion Tube with Stylet, Sterile, at target, for use with Nexframe and Nexdrive
Catalog Number
66-IT-DB12P
Brand Name
microTargeting™ Insertion Tube
Version/Model Number
66-IT-DB12P-00327
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
K011775,K011775
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
d88f27ba-7f02-43ce-bc1d-01f496d1cf39
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
10873263003272
Quantity per Package
5
Contains DI Package
00873263003275
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 |