Duns Number:305682023
Device Description: Ambu Neuroline Cup, 200 cm leadwire, Colour Kit of 25 pcs .
Catalog Number
72620-M/25
Brand Name
Neuroline Cup
Version/Model Number
72620-M/25
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
GXY
Product Code Name
Electrode, cutaneous
Public Device Record Key
9bb5f726-61c5-4dc6-8ec4-b29548065e12
Public Version Date
June 09, 2021
Public Version Number
1
DI Record Publish Date
June 01, 2021
Package DI Number
05707480146659
Quantity per Package
2
Contains DI Package
05707480146666
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 |