Duns Number:305682023
Device Description: Ambu Neuroline CUP Elektrode With male 1,5 mm Connector and wire length of 200 cm
Catalog Number
72620-M/10
Brand Name
Neuroline CupNeurology Surface Electrodes
Version/Model Number
72620-M/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"
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
-
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
8551c81f-7229-4423-a84f-194f6ff332fb
Public Version Date
December 19, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
05707480029419
Quantity per Package
46
Contains DI Package
05707480029426
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 |