Duns Number:959181160
Device Description: ClearPoint Inflexion Head Fixation Frame/Table Mount for IMRIS Aera-Skyra tables.
Catalog Number
CP-INHFF-242-01
Brand Name
ClearPoint
Version/Model Number
CP-INHFF-242-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
K191701
Product Code
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
Public Device Record Key
589c8d2c-43ce-4c1b-844b-718603806f5d
Public Version Date
June 21, 2022
Public Version Number
2
DI Record Publish Date
February 12, 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 |