Catalog Number

-

Brand Name

Single Use Retrieval Nitinol Basket V

Version/Model Number

FG-V451P

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

K170811,K170811

Product Code

LQR

Product Code Name

DISLODGER, STONE, BILIARY

Public Device Record Key

6a1db9e3-e68d-4cfe-aff3-35fc5953c168

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

March 14, 2018

Package DI Number

14953170395328

Quantity per Package

1

Contains DI Package

04953170395321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-