Catalog Number

HNBR5.0-38-125-P-NS-SIM2

Brand Name

Beacon Tip Torcon NB

Version/Model Number

G11517

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"

-

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

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

95c6dc89-2ac6-4716-b088-fd7d427e4cb5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2018

Package DI Number

10827002115177

Quantity per Package

5

Contains DI Package

00827002115170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-