Duns Number:305682023
Device Description: Ambu Neuroline Subdermal - White wires only - USA
Catalog Number
74512-150/24W
Brand Name
Neuroline SubdermalNeurology Needle Electrodes
Version/Model Number
74512-150/24W
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2018
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
IKT
Product Code Name
Electrode, needle, diagnostic electromyograph
Public Device Record Key
f268d423-733a-451a-a561-f7453eea85c2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
05707480121427
Quantity per Package
24
Contains DI Package
05707480121410
Package Discontinue Date
March 09, 2018
Package Status
Not 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 |