Catalog Number

37.015.21

Brand Name

Urethrotome cold-knife,straight 21Ch.

Version/Model Number

37.015.21

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Public Device Record Key

b1345992-ff97-41d2-8189-58a23d98c19d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH37015211

Quantity per Package

1

Contains DI Package

EMAH37015210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-