Catalog Number

-

Brand Name

Urethrotomy knife

Version/Model Number

195 400 110

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K971881

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Public Device Record Key

515cf68a-bcf3-4b62-8ad4-68041dbd4927

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-