Duns Number:081277700
Device Description: REPLACEMENT TOOL, ADJUSTABLE HEIGHT LOCATOR for use ONLY as part of the CODMAN CERTAS TOOL REPLACEMENT TOOL, ADJUSTABLE HEIGHT LOCATOR for use ONLY as part of the CODMAN CERTAS TOOL KIT (REF: 82-8851)
Catalog Number
82-8861
Brand Name
CODMAN CERTAS®
Version/Model Number
828861
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
6a1672c5-0aba-4e7b-a56e-fbcef44f5dc0
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 |