Duns Number:962519208
Device Description: ER2/Broadband Insert Earphone Disposable Foam Tips for adults and for use with 580-ER2INS ER2/Broadband Insert Earphone Disposable Foam Tips for adults and for use with 580-ER2INS
Catalog Number
202125
Brand Name
Bio-logic
Version/Model Number
Insert Earphone Tip ER2 Adult
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
K031352,K031352
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
5a0904e2-7be1-4b36-a5d6-e1c06c8a7dc0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 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 |