Catalog Number

-

Brand Name

TRIA® II Display Doppler with 8.0 MHz Sterilizable Vascular Probe

Version/Model Number

DMT337-DS

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

K991441

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

1b5bd2f7-00b2-496b-98d7-f82cb11396d4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-