Catalog Number

-

Brand Name

Novatome

Version/Model Number

SU103-100PC

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

K072051

Product Code

DWZ

Product Code Name

Device, Biopsy, Endomyocardial

Public Device Record Key

155709fa-3794-4c80-8953-ec5fc76e442f

Public Version Date

January 29, 2020

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-