Duns Number:108179458
Device Description: microTargeting(TM) Electrode, 6x, non-sterile, for use with Nexframe(R) and STar Drive
Catalog Number
5730R
Brand Name
microTargeting™ Electrode
Version/Model Number
5730R-00579
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
K033173,K033173
Product Code
GZL
Product Code Name
ELECTRODE, DEPTH
Public Device Record Key
893556f8-8eec-4079-b21e-c3958012d5eb
Public Version Date
September 23, 2019
Public Version Number
4
DI Record Publish Date
March 03, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |