Catalog Number

GL0101U

Brand Name

TraxerFlow use with gravity - Irrigation Line for Laser Ureteroscopy

Version/Model Number

GL0101U

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

e7befa8d-798d-4dca-9904-9451e907a40a

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

03700512911531

Quantity per Package

10

Contains DI Package

03700512901532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 1