Duns Number:418415568
Device Description: Monopolar Probe 214x3mm & sheath/cable 1pc
Catalog Number
-
Brand Name
Technomed Europe
Version/Model Number
MP214-3.0/1
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
-
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
fa8d19fb-b16c-4d0a-92a2-06d8884903b1
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
April 10, 2019
Package DI Number
08718375866313
Quantity per Package
1
Contains DI Package
08718375866306
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 429 |