Catalog Number

36.013.19SL

Brand Name

HF-roller ball resectoscopy electrode, roller diam.3.0mm,24Ch

Version/Model Number

36.013.19SL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

JFL

Product Code Name

pH rate measurement, carbon-dioxide

Public Device Record Key

38d915cd-7928-43f7-85b6-8cfd178bb64b

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

December 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-