Duns Number:458670304
Device Description: NETCELL 12mm Ear Wick
Catalog Number
-
Brand Name
NETCELL
Version/Model Number
30-301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 18, 2021
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
-
Product Code
KCN
Product Code Name
Ear Wick
Public Device Record Key
95dd37f6-6948-49e2-b57e-f97451603cc9
Public Version Date
January 19, 2021
Public Version Number
2
DI Record Publish Date
August 06, 2019
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 | 329 |
2 | A medical device with a moderate to high risk that requires special controls. | 51 |