Catalog Number

4011519

Brand Name

MYELO-NATE

Version/Model Number

Needle Only

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

-

Product Code

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

f0979091-a8ef-4125-8d17-cc526b5a48b8

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

H67140115191

Quantity per Package

30

Contains DI Package

H67140115190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-