Zephyr Patient Positioning and Transfer System - Zephyr Docking Kit 53cm for Elekta iBeam Couch - DIACOR, INC.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIACOR, INC." Characteristics
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