Catalog Number

700-0906-01

Brand Name

UltraviewSL

Version/Model Number

91496

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2019

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"

Yes

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

K103142

Product Code

DXG

Product Code Name

COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Public Device Record Key

1f3d8041-f7b3-437c-a7c8-8d4aca5ff49e

Public Version Date

January 31, 2019

Public Version Number

5

DI Record Publish Date

March 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-