Duns Number:201740425
Device Description: EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI is comprise EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
Catalog Number
-
Brand Name
EarDome
Version/Model Number
100004
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043396
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
81ec1f11-d8c1-4733-960d-197c5e9ca52d
Public Version Date
April 21, 2020
Public Version Number
2
DI Record Publish Date
October 29, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |