Catalog Number

ROMYTB-ST0

Brand Name

Y MMLL + Tuohy Borst 9 FR (11G)

Version/Model Number

ROMYTB-ST0

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

ea2bd5ed-6ace-44ba-b03f-3b19c878abcb

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

03700512981930

Quantity per Package

16

Contains DI Package

03700512971931

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2