Catalog Number

ET2012

Brand Name

SwirlNet

Version/Model Number

ET2012

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"

Yes

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

-

Product Code

FGX

Product Code Name

Snare, Non-Electrical

Public Device Record Key

3a913193-9728-457d-9930-5822dc0e10fa

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

10816207021093

Quantity per Package

10

Contains DI Package

00816207021096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box