Catalog Number

SOUR9208ST12

Brand Name

Urology Diagnostic TURP 2 Spike

Version/Model Number

RF2TUPD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

FHF

Product Code Name

System, Evacuator, Fluid

Public Device Record Key

c5a9608d-709a-4481-913b-90c2b52e1433

Public Version Date

February 11, 2020

Public Version Number

3

DI Record Publish Date

October 21, 2019

Package DI Number

03700512922070

Quantity per Package

2

Contains DI Package

03700512912071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box Label 2