Catalog Number

ET2011

Brand Name

SwirlNet

Version/Model Number

ET2011

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

7b5a6416-9788-4d74-889f-aded205edb59

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

10816207021086

Quantity per Package

5

Contains DI Package

00816207021089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box