Catalog Number

6571004

Brand Name

DRYVIEW 5950 Laser Imaging System

Version/Model Number

DRYVIEW 5950 Laser Imaging System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2021

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

c21efb3e-f3dd-4139-aa24-7cc807ed7e40

Public Version Date

June 23, 2021

Public Version Number

5

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-