Duns Number:962519208
Device Description: Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used wit Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used with Natus hearing screeners.
Catalog Number
011445
Brand Name
Bio-Logic Algo Supplies
Version/Model Number
011445
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
983cd1ce-7080-45cb-a3b9-f02b69739e22
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2018
Package DI Number
00382830054485
Quantity per Package
4
Contains DI Package
00382830001885
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |