Zephyr Patient Positioning and Transfer System - Zephyr HDR Accessory - Trumpf Table Kit End Stop, - DIACOR, INC.

Duns Number:605813559

Device Description: Zephyr HDR Accessory - Trumpf Table Kit End Stop, radiolucent version

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More Product Details

Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZEP-ATS-02

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

FRZ

Product Code Name

Device, Patient Transfer, Powered

Device Record Status

Public Device Record Key

706e0e24-0c53-4967-85d1-2c9b37a8404f

Public Version Date

December 29, 2021

Public Version Number

1

DI Record Publish Date

December 21, 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