Duns Number:959181160
Device Description: A procedure kit that packages several individually boxed and packaged ClearPoint kits tog A procedure kit that packages several individually boxed and packaged ClearPoint kits together. Contains the SmartFrame XG-5.
Catalog Number
CP-NGS-11-TP45-XG-5
Brand Name
SmartFrame XG TwistPoint Kit w/TE-5 Fr
Version/Model Number
CP-NGS-11-TP45-XG-5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 30, 2035
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
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
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
7b669827-e045-4360-bf59-41f3b45b45cb
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
January 22, 2021
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |