Duns Number:108179458
Device Description: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
Catalog Number
MTDWZP(AR)(AR7)
Brand Name
microTargeting™ Electrode
Version/Model Number
MTDWZP(AR)(AR7)-00865
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
K033173,K033173
Product Code
GZL
Product Code Name
ELECTRODE, DEPTH
Public Device Record Key
442b0671-200e-4a1a-a7b4-97bcd7ecab16
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
10873263008659
Quantity per Package
5
Contains DI Package
00873263008652
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 |