Catalog Number

MC-RAN-11CX

Brand Name

MC-RAN-11CX Bone Marrow Aspiration Needle

Version/Model Number

11 Gauge X 3.5"

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

K150563,K150563,K150563

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

f2808230-c7af-46a5-96c2-0a6cb859cb69

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

October 27, 2016

Package DI Number

10858690006331

Quantity per Package

1

Contains DI Package

00858690006334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER PACK