Duns Number:605813559
Device Description: Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop bar and ( Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit.
Catalog Number
-
Brand Name
Zephyr Patient Positioning and Transfer System
Version/Model Number
ZXL-ADK-07
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K121929
Product Code
LHN
Product Code Name
System, Radiation Therapy, Charged-Particle, Medical
Public Device Record Key
9f4f2e1c-c47e-41b4-a01c-76df1151a50e
Public Version Date
December 30, 2021
Public Version Number
1
DI Record Publish Date
December 22, 2021
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 107 |