Catalog Number

MC-RAN-13FAB

Brand Name

MC-RAN-13FAB

Version/Model Number

13Gauge X 5CM

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"

Yes

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

K150563,K150563,K150563

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

ab9cb2ad-9c72-4a39-8b77-73c10f535eda

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

August 10, 2018

Package DI Number

20857878007099

Quantity per Package

30

Contains DI Package

10857878007092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case