Duns Number:108179458
Device Description: microTargeting(TM) Electrode, sterile, 5x, D.ZAP(L), for use with Platform
Catalog Number
MTDPLP(PA)(MP1)
Brand Name
microTargeting™ Electrode
Version/Model Number
MTDPLP(PA)(MP1)-00640
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
aba531d7-66a2-4674-a996-f91aac491ed6
Public Version Date
September 23, 2019
Public Version Number
4
DI Record Publish Date
January 23, 2018
Package DI Number
10873263006402
Quantity per Package
5
Contains DI Package
00873263006405
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 |