Duns Number:108179458
Device Description: microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insert microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insertion Tube - 205.6mm tube length, 1.83mm od, 1.6mm id PT(KH1): Protective Tube - 0.58mm id. Nexframe Stylet.
Catalog Number
66-IT-4010S
Brand Name
microTargeting™ NexFrame® Insertion Tube Kit
Version/Model Number
66-IT-4010S-00848
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
f03178a0-49ca-45d6-8b8d-8e8c9a268893
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 07, 2021
Package DI Number
10873263008482
Quantity per Package
5
Contains DI Package
00873263008485
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 |