Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZXL-AOT-15

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

b4f6d418-dd32-4236-bf94-261d39391292

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

-