Catalog Number

HNB5.0-38-100-P-NS-H3-01

Brand Name

Torcon NB

Version/Model Number

G58425

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

9848a333-8ecc-4386-bcdc-20d1b068963d

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Package DI Number

10827002584256

Quantity per Package

5

Contains DI Package

00827002584259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each