Duns Number:081277700
Device Description: REPLACEMENT TOOL, INDICATOR for use ONLY as part of the CODMAN CERTAS TOOL KIT (REF: 82-88 REPLACEMENT TOOL, INDICATOR for use ONLY as part of the CODMAN CERTAS TOOL KIT (REF: 82-8851)
Catalog Number
82-8860
Brand Name
CODMAN CERTAS®
Version/Model Number
828860
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K143111
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
a75d1578-28d5-41b2-88fa-9b4cf41c5384
Public Version Date
May 13, 2021
Public Version Number
3
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 |