Catalog Number

CESLL5070

Brand Name

BREEZE CENTESIS DRAINAGE CATHETER

Version/Model Number

CESLL5070

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

7a7cff91-fa08-4f3f-947f-40c9d1718183

Public Version Date

January 28, 2022

Public Version Number

1

DI Record Publish Date

January 20, 2022

Package DI Number

50884908163754

Quantity per Package

10

Contains DI Package

00884908163759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box