Duns Number:108179458
Device Description: WayPoint Navigator - Laptop
Catalog Number
C0240
Brand Name
WayPoint™ Navigator
Version/Model Number
C0240-00783
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K092192
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
e23fb4ee-5385-4a4e-9bce-599282f1f05a
Public Version Date
July 17, 2019
Public Version Number
1
DI Record Publish Date
July 09, 2019
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 476 |