Catalog Number

-

Brand Name

DRGEM

Version/Model Number

TOPAZ-32D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K183292,K201124

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

0a70cfa8-c86c-4bfa-bdc8-0518854e6f9c

Public Version Date

May 26, 2020

Public Version Number

3

DI Record Publish Date

May 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-