Duns Number:034824691
Device Description: Complete Carbon Fibre SBRT System, including Baseplate, Wingboard, T-Bar, 2 Arches, 2 Vacu Complete Carbon Fibre SBRT System, including Baseplate, Wingboard, T-Bar, 2 Arches, 2 Vacuum Bags, knee cushion and feet cushion.
Catalog Number
-
Brand Name
Klarity Medical
Version/Model Number
R62400-CF
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112460
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
bf617eac-a2cc-4cd7-857d-038ea22c67d2
Public Version Date
September 16, 2020
Public Version Number
4
DI Record Publish Date
November 20, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 483 |