Catalog Number

-

Brand Name

Evident

Version/Model Number

VT1720

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 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

Yes

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

K032702

Product Code

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Public Device Record Key

53cacd6b-9d7a-4f1d-9473-9b144af80af5

Public Version Date

December 17, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-