Catalog Number

RM0279-01

Brand Name

NuMED, Inc. Bonhoeffer

Version/Model Number

J3FC-SS C 210-035

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

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

c7400de2-7235-4d1c-a7a3-1f636955f1e3

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

10887714030380

Quantity per Package

5

Contains DI Package

10887714024532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single Pack Sterile