Catalog Number

6559355

Brand Name

DRYVIEW 5700 Laser Imaging System

Version/Model Number

DRYVIEW 5700 Laser Imaging System

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

-

Product Code

LMC

Product Code Name

Camera, multi format, radiological

Public Device Record Key

ce8c2e3a-2bf6-44a0-b316-a78ef1d2e324

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

April 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-