Zephyr Patient Positioning and Transfer System - Zephyr XL Patient Hover Board for GE MRI Scanners - DIACOR, INC.

Duns Number:605813559

Device Description: Zephyr XL Patient Hover Board for GE MRI Scanners

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More Product Details

Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZXL-ZGE-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

FRZ

Product Code Name

Device, Patient Transfer, Powered

Device Record Status

Public Device Record Key

e70c969e-e7a0-4fba-9845-e7ee0ae1e058

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

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