Duns Number:305682023
Device Description: Ambu Disposable IOM Stimulation Probes 100 mm long Monopolar Needle with 1,5 mm connector Ambu Disposable IOM Stimulation Probes 100 mm long Monopolar Needle with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale
Catalog Number
73601-190/10
Brand Name
Ambu Monopolar ProbeSingle Patient Probes
Version/Model Number
73601-190/10
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
199e5062-b948-466e-b562-183e28eec07c
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
05707480108527
Quantity per Package
10
Contains DI Package
05707480108510
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |