Duns Number:017283879
Device Description: The TGS Universal Headrest is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. It also provides a resting surfaced for the patient to place their head during procedures requiring navigation.
Catalog Number
-
Brand Name
TGS Universal Headrest
Version/Model Number
8000-010-007
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
K193502
Product Code
PGW
Product Code Name
Ear, Nose, And Throat Stereotaxic Instrument
Public Device Record Key
37817bfb-e5d8-4c1b-8dd4-18e6b1dc2348
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 2020
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 |