Catalog Number

RBN-116

Brand Name

Bone Marrow Biopsy Needle, RBN-116

Version/Model Number

11 Gauge x 6"

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

K983187,K983187,K983187

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

3fe391c9-699b-482b-a00c-e6c4e85e4334

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

Package DI Number

20857878007600

Quantity per Package

8

Contains DI Package

10857878007603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case