Catalog Number

108800

Brand Name

VTI 8 MHz Trans-Q-taneous Intraoperative Doppler System

Version/Model Number

108800

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

K082870

Product Code

DPW

Product Code Name

FLOWMETER, BLOOD, CARDIOVASCULAR

Public Device Record Key

871bce91-da5b-466f-9f91-46ccc624d3ae

Public Version Date

January 29, 2020

Public Version Number

1

DI Record Publish Date

January 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-