Catalog Number

SWF-HP01

Brand Name

Swift Applicator Handpiece

Version/Model Number

SWF-HP01

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

K181941

Product Code

NEY

Product Code Name

System, Ablation, Microwave And Accessories

Public Device Record Key

6c5dc960-842a-4bcd-98c5-e61225608506

Public Version Date

February 04, 2019

Public Version Number

1

DI Record Publish Date

January 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-