Duns Number:500375274
Device Description: To fit 6 or 7mm endotracheal tubes
Catalog Number
-
Brand Name
Neurosign Lantern Laryngeal Electrode 6/7mm
Version/Model Number
4201-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 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
ETN
Product Code Name
Stimulator, Nerve
Public Device Record Key
77140165-f509-4a9c-b7f4-aa8da327d54c
Public Version Date
August 30, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
15060229531398
Quantity per Package
10
Contains DI Package
05060229531391
Package Discontinue Date
February 25, 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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 92 |