Catalog Number

RF201U2S

Brand Name

Urology - TRAXERFLOW -2 Way Irrigation set Ureteroscopy with laser

Version/Model Number

RF201U2S

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

ad1448bf-bc46-4cb7-9205-0cee9bc83457

Public Version Date

January 01, 2020

Public Version Number

7

DI Record Publish Date

November 24, 2016

Package DI Number

03700512921653

Quantity per Package

4

Contains DI Package

03700512911654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4