Catalog Number

-

Brand Name

Single Use Electrosurgical Snare SD-400

Version/Model Number

SD-400U-10

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

FDI

Product Code Name

SNARE, FLEXIBLE

Public Device Record Key

f2334537-7f2d-4238-90f0-3eeba7c921ab

Public Version Date

May 24, 2022

Public Version Number

2

DI Record Publish Date

December 11, 2020

Package DI Number

14953170408240

Quantity per Package

10

Contains DI Package

04953170408243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-