Duns Number:959181160
Device Description: Array Kit with navigation frame, used mainly for burr hole procedures
Catalog Number
NGS-SFA-02-2
Brand Name
SmartFrame Array
Version/Model Number
NGS-SFA-02-2
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
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
K202575
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
5d3f5e10-175b-40fb-aeb5-768174e4fa11
Public Version Date
June 22, 2022
Public Version Number
2
DI Record Publish Date
July 14, 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 |