Catalog Number

MC-RAN-13FA

Brand Name

MC-RAN-13FA

Version/Model Number

13 Gauge x 2in

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

K131157,K131157,K131157

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

d147f674-01c7-4356-bb44-35e41b7b2ba0

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Package DI Number

10850023741131

Quantity per Package

1

Contains DI Package

00850023741134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER PACK