Duns Number:332785323
Catalog Number
-
Brand Name
NPS2 CODMAN
Version/Model Number
091978-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 24, 2017
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
GWM
Product Code Name
Device, Monitoring, Intracranial Pressure
Public Device Record Key
c04586c6-d720-42ee-8b72-b8ee7cc40e5c
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
August 18, 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. | 60 |