Catalog Number

GL0201T2SCL

Brand Name

Irrigation set for RTUP / Laser - 2 spikes + line fiber laser cooling

Version/Model Number

GL0201T2SCL

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

7959bb20-0505-4442-9b78-7aacafce4e61

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

03700512921523

Quantity per Package

4

Contains DI Package

03700512911524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2