Duns Number:017283879
Device Description: The Field Generator Stand is a reusable device intended to be used with the Stryker ENT Na The Field Generator Stand is a reusable device intended to be used with the Stryker ENT Navigation System. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an EM field.
Catalog Number
-
Brand Name
TGS Field Generator Stand
Version/Model Number
8000-014-005
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
-
Product Code
QLV
Product Code Name
Field Generator Positioning Device
Public Device Record Key
e238ab87-9d2e-4551-bd4f-578fb8bcbdbe
Public Version Date
January 12, 2022
Public Version Number
1
DI Record Publish Date
January 04, 2022
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |