Duns Number:015903922
Device Description: Malleable Monopolar Probe with 2.25mm Ball-Tip 100mm electrode (handle to tip) 2m cable wi Malleable Monopolar Probe with 2.25mm Ball-Tip 100mm electrode (handle to tip) 2m cable with DIN42802 Connector
Catalog Number
-
Brand Name
MytaMed
Version/Model Number
ME3604-00
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
K100912,K100912,K100912
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
d7a2271a-78f8-49a0-bc77-f8399087f515
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
July 10, 2016
Package DI Number
20841019110229
Quantity per Package
50
Contains DI Package
00841019110225
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 861 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |