Catalog Number

39.007.50QL

Brand Name

Laser Cysto examination insert w.8Fr. working channel

Version/Model Number

39.007.50QL

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

5e41360a-5e55-42b4-9ed9-1a2b227da498

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH3900750QL1

Quantity per Package

1

Contains DI Package

EMAH3900750QL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-