Catalog Number

0653665

Brand Name

Irrigation Set

Version/Model Number

653665

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

cae3f19e-af36-4815-93c0-de41d59e733f

Public Version Date

July 30, 2018

Public Version Number

1

DI Record Publish Date

June 28, 2018

Package DI Number

20887787006692

Quantity per Package

20

Contains DI Package

10887787006695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case