Duns Number:069799474
Device Description: Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model
Catalog Number
NM-0262
Brand Name
CERVELLO 64 W
Version/Model Number
NM-0262
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
9fdb6c2e-14d5-4815-b960-c089919e8ab8
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 |