Duns Number:529249095
Catalog Number
-
Brand Name
Natus
Version/Model Number
017513
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
K112426,K112426
Product Code
ETN
Product Code Name
Stimulator, Nerve
Public Device Record Key
ca3182fe-ecba-435b-b2c7-74cab636ef2c
Public Version Date
September 20, 2021
Public Version Number
4
DI Record Publish Date
December 28, 2017
Package DI Number
26955739013587
Quantity per Package
1
Contains DI Package
16955739013580
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 111 |