Catalog Number

ROMTB-ST0

Brand Name

Tuohy Borst connector

Version/Model Number

09-0029

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

d1a12859-0f95-4185-89a8-255d9261bb7d

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

November 09, 2017

Package DI Number

03700512986331

Quantity per Package

16

Contains DI Package

03700512976332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box