Catalog Number

-

Brand Name

Single Use Loop Cutter FS-410

Version/Model Number

FS-410L

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

PTS

Product Code Name

Endoscopic grasping/cutting instrument, non-powered, exempt

Public Device Record Key

bab7061f-c910-4839-8631-990752ac2ff1

Public Version Date

December 17, 2021

Public Version Number

3

DI Record Publish Date

August 21, 2018

Package DI Number

14953170401036

Quantity per Package

1

Contains DI Package

04953170401039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-