Catalog Number

RF0501T2CL

Brand Name

Irrigation tubing set for RTUP with Laser fiber cooling line - 2 spikes

Version/Model Number

RF0501T2CL

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

4fff95a4-fd09-4db0-9342-c880b3bd3403

Public Version Date

November 11, 2019

Public Version Number

6

DI Record Publish Date

September 14, 2016

Package DI Number

03700512921707

Quantity per Package

4

Contains DI Package

03700512911708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2