Duns Number:009120817
Device Description: Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws
Catalog Number
-
Brand Name
Varian Head Frame Package
Version/Model Number
P1006805002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 2018
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
K142560
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
4423f871-d5d1-4bd3-8c1b-9b4ea3a326c1
Public Version Date
December 09, 2019
Public Version Number
4
DI Record Publish Date
September 10, 2016
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 253 |