Catalog Number

-

Brand Name

Urethrotomy sheath

Version/Model Number

195 110 050

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

EZO

Product Code Name

Urethrotome

Public Device Record Key

2e4016d9-5834-46df-8c71-0b1646af3d64

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

March 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-