Duns Number:108179458
Device Description: microTargeting™ Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar microTargeting™ Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
Catalog Number
MTDWZN(AR)(AR7)
Brand Name
microTargeting™ Electrode
Version/Model Number
MTDWZN(AR)(AR7)-00863
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
8de219d8-af4b-4902-ac78-dff240519b3b
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
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 |