Catalog Number

50024

Brand Name

Biliary Stone Basket

Version/Model Number

50024

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K925559

Product Code

LQR

Product Code Name

Dislodger, Stone, Biliary

Public Device Record Key

c767140f-fb4c-42bf-8ffd-4e1784d8b147

Public Version Date

November 06, 2020

Public Version Number

5

DI Record Publish Date

May 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-