Catalog Number

RAN-11B

Brand Name

RAN-11B, F/G

Version/Model Number

11 Gauge x 110mm

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

d8e2f07d-0d08-4347-ae78-97108fa94d0b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2017

Package DI Number

10858690006171

Quantity per Package

10

Contains DI Package

00858690006174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack