Catalog Number

RAN-16(2.8)N5T

Brand Name

RAN-16(2.8), F/G

Version/Model Number

16GA x 2.8"

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

edf14122-25c5-407a-89bb-54f7ecd4649f

Public Version Date

February 03, 2022

Public Version Number

4

DI Record Publish Date

May 04, 2017

Package DI Number

20858690006895

Quantity per Package

8

Contains DI Package

10858690006898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case