Catalog Number

5407010970

Brand Name

N/A

Version/Model Number

5407-010-970

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

bbc74c7d-5ba1-456c-8fd5-e26b4d7886f4

Public Version Date

April 23, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2018

Package DI Number

37613327381444

Quantity per Package

10

Contains DI Package

07613327381443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack