Catalog Number

SOUR9200ST12

Brand Name

Urology - TURP / POST OPERATIVE Irrigation/Aspiration set (WITH PUMP SEGMENT)

Version/Model Number

SOUR9200ST12

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

a2c37b6f-4c3b-4c9e-92b0-22fc2df249f1

Public Version Date

November 11, 2019

Public Version Number

6

DI Record Publish Date

October 11, 2016

Package DI Number

03700512921127

Quantity per Package

2

Contains DI Package

03700512911128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2