Catalog Number

G65X

Brand Name

RAN-1115H2S C#0002262

Version/Model Number

11 Gauge X 15.24CM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

8046978d-b508-4a47-9c36-6d7fe4763902

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 09, 2017

Package DI Number

M979G65X9

Quantity per Package

30

Contains DI Package

M979G65X1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case