Catalog Number

MC-RAN-13FA

Brand Name

Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM

Version/Model Number

13GA X 5CM

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

f5c6b07c-00e1-40b9-986d-83a26968b952

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 07, 2018

Package DI Number

20857878007082

Quantity per Package

10

Contains DI Package

10857878007085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case