Catalog Number

0600-2150-000

Brand Name

Line

Version/Model Number

0600-2150-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2020

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

b231e9ed-ab56-455f-8a1e-af1990667875

Public Version Date

January 13, 2020

Public Version Number

2

DI Record Publish Date

January 29, 2019

Package DI Number

10817984011031

Quantity per Package

20

Contains DI Package

00817984011034

Package Discontinue Date

January 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Inner pack