Catalog Number

-

Brand Name

ClearGrasp Snare

Version/Model Number

FM-ESN002(2400)(Stiff)A

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

K183289,K183289

Product Code

FDI

Product Code Name

Snare, Flexible

Public Device Record Key

f57e3c83-df95-46a0-a151-4bed6db39b77

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Package DI Number

18809327351838

Quantity per Package

10

Contains DI Package

08809327351831

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box