Catalog Number

RBN-84

Brand Name

Bone Marrow Biopsy Needle, RBN-84

Version/Model Number

8 Gauge x 4"

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

cb55ebe3-6762-4bb1-abe0-99ad21c3d7d2

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Package DI Number

10850023741070

Quantity per Package

10

Contains DI Package

00850023741073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack