Catalog Number

504300

Brand Name

Biopsy Forceps

Version/Model Number

504300

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

K810849,K810849

Product Code

DWZ

Product Code Name

DEVICE, BIOPSY, ENDOMYOCARDIAL

Public Device Record Key

664f96f9-91a8-4cb4-8b96-8ecee8ac38dd

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

January 26, 2021

Package DI Number

20705032056097

Quantity per Package

1

Contains DI Package

10705032056090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX