Duns Number:108179458
Device Description: microTargeting Sterotactic Frame Insertion Tube Set, 5X Contains: IT(BP13): Insertion Tu microTargeting Sterotactic Frame Insertion Tube Set, 5X Contains: IT(BP13): Insertion Tube - 194mm tube length, 1.83mm od, 1.6mm idPT(BP13): Protective Tube - 1.0mm idSA8-87-02: Stylet - 266.4mm length
Catalog Number
66-IT-14S
Brand Name
microTargeting™ Insertion Tube
Version/Model Number
66-IT-14S-00620
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
dbfadec7-aab2-47cb-991f-ed60d9503e3e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 06, 2017
Package DI Number
10873263006204
Quantity per Package
5
Contains DI Package
00873263006207
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 |