Catalog Number

Z263001

Brand Name

Irrigation Tube

Version/Model Number

OSG00499E10ST35

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"

-

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

e2c57808-cf61-49f5-b32f-82ef6dcfcb1c

Public Version Date

April 23, 2019

Public Version Number

3

DI Record Publish Date

April 06, 2018

Package DI Number

03700512925026

Quantity per Package

10

Contains DI Package

03700512915027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box