Duns Number:962519208
Device Description: Infant Ear Tip, Transparent Blue, Size 5.5 mm, Qty 50
Catalog Number
1911-US
Brand Name
Natus
Version/Model Number
Infant Ear Tip 5.5 mm
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013977,K013977
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
478dd06b-1669-4a17-9a22-3b4e850f6f08
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 29, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |