Duns Number:081277700
Device Description: ICP Monitor
Catalog Number
826820
Brand Name
CODMAN CERTAS®
Version/Model Number
826820
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K183406
Product Code
GWM
Product Code Name
Device, monitoring, intracranial pressure
Public Device Record Key
0c67d82d-4469-4d30-9ecd-ead4143eb4e9
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 28, 2020
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |