Duns Number:069799474
Device Description: JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bi JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bipolar, to be used with CERVELLO 32 Series Headboxes
Catalog Number
7512
Brand Name
JB CERVELLO 32
Version/Model Number
7512
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
-
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
GWK
Product Code Name
Conditioner, Signal, Physiological
Public Device Record Key
18cb576d-738e-45a7-ac61-99685b3d8cec
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |