Catalog Number

RBN-114

Brand Name

NDL, RBN-114, STERILE, F/G

Version/Model Number

11 GAUGE x 4"

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

K983187,K983187,K983187

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

69e9b85a-85c7-4bcf-a47b-46c267a3e799

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2017

Package DI Number

M9797405001M9

Quantity per Package

12

Contains DI Package

M9797405001M1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case