Duns Number:962519208
Device Description: OAE Pediatric Foam Ear Tip
Catalog Number
203201, 29425
Brand Name
Bio-logic
Version/Model Number
OAE Foam Tip Pediatric
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
K111618,K112247,K121512,K122496,K111618,K112247,K121512,K122496
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
1ba6986e-d1e8-4f62-947e-2e33a663112a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 30, 2016
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 |