Zephyr Patient Positioning and Transfer System - Zephyr Docking Side Stop Bar - (1): Used on 53cm - DIACOR, INC.

Duns Number:605813559

Device Description: Zephyr Docking Side Stop Bar - (1): Used on 53cm Elekta iBeam Couch

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More Product Details

Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZXL-ASB-03

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

552b9272-4d95-48a6-9691-c9987227afac

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