Catalog Number

36.006.00RQL

Brand Name

Continuous-flow resectoscope sheath, compl.,rotatable,perf.all around,26Ch.

Version/Model Number

36.006.00RQL

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

a5872fc3-9f6a-495f-962f-90363f455d68

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH3600600RQL1

Quantity per Package

1

Contains DI Package

EMAH3600600RQL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-