Catalog Number

36.005.02

Brand Name

Resectoscopy working unit,active, closed handle,24/26/28.5Ch

Version/Model Number

36.005.02

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

-

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

-

FDA Premarket Submission

-

Product Code

FDC

Product Code Name

RESECTOSCOPE, WORKING ELEMENT

Public Device Record Key

5bc8347d-36c7-47d3-bfba-76324f4e9ccf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-