Duns Number:046355210
Device Description: Bipolar Nerve Stimulator Probe, Side x Side 4" (100mm) x 0.8mm electrodes 2m Cable with DI Bipolar Nerve Stimulator Probe, Side x Side 4" (100mm) x 0.8mm electrodes 2m Cable with DIN42802 Connectors
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
41-3401
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"
Yes
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
ce5ca944-01db-4b38-acc0-506030abcbaa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 08, 2016
Package DI Number
20841019108172
Quantity per Package
50
Contains DI Package
00841019108178
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 | 60 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1505 |
| U | Unclassified | 2 |