Catalog Number

-

Brand Name

SparrowHawk

Version/Model Number

5031

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

K010473,K010473

Product Code

DWZ

Product Code Name

Device, Biopsy, Endomyocardial

Public Device Record Key

a6ad5062-0f6f-4a68-a39c-08aa49e9ccfd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00817428020219

Quantity per Package

5

Contains DI Package

00817428020202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-