Catalog Number

RF16H545

Brand Name

Irrigation/Aspiration probe 16 holes, 5mmx45cm

Version/Model Number

RF16H545

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

404b2725-e1c5-49a8-8ec0-d53165f0edf1

Public Version Date

August 20, 2019

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

03700512921479

Quantity per Package

60

Contains DI Package

03700512911470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2