Catalog Number

SEH25120

Brand Name

Nitinol Stone Extractor Helical 2.5F x 120cm

Version/Model Number

SEH25120

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

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Public Device Record Key

a21ba003-d6b6-4a91-af92-d1379da5c191

Public Version Date

January 01, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

03700512985501

Quantity per Package

4

Contains DI Package

03700512975502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2