Duns Number:108179458
Device Description: microTargeting™ Single Electrode Insertion Tube Set with Bullet TipStylet at target, 1x, S microTargeting™ Single Electrode Insertion Tube Set with Bullet TipStylet at target, 1x, Sterile. Contains:IT(BP11) Insertion Tube – 219mm tube length, 1.83mm od, 1.6mm idPT(JN11) Protective Tube - 1.27mm od, .84mm id
Catalog Number
66-IT-11P
Brand Name
microTargeting™ Insertion Tube Set
Version/Model Number
66-IT-11P-00801
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
8df65930-d152-411c-b9f2-ae6db7b066af
Public Version Date
August 02, 2019
Public Version Number
1
DI Record Publish Date
July 25, 2019
Package DI Number
10873263008017
Quantity per Package
5
Contains DI Package
00873263008010
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 |