Catalog Number

SWST-1415

Brand Name

SynchroWave Antenna Kit

Version/Model Number

SWST-1415

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

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

K141785

Product Code

NEY

Product Code Name

System, Ablation, Microwave And Accessories

Public Device Record Key

69393506-7d46-447d-b99b-5ae13fbdae0b

Public Version Date

July 03, 2020

Public Version Number

3

DI Record Publish Date

April 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-