Zephyr Patient Stretcher - Zephyr MR Conditional Stretcher - DIACOR, INC.

Duns Number:605813559

Device Description: Zephyr MR Conditional Stretcher

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More Product Details

Catalog Number

-

Brand Name

Zephyr Patient Stretcher

Version/Model Number

ZTG-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

-

Product Code Details

Product Code

FPO

Product Code Name

Stretcher, Wheeled

Device Record Status

Public Device Record Key

a7fcb0c7-360e-42c2-9f02-fd49c4b0d94d

Public Version Date

March 29, 2018

Public Version Number

2

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