Catalog Number

CRVS-BMA-FA

Brand Name

Cervos Foot and Ankle Bone Marrow Aspiration Needle

Version/Model Number

13 Gauge X 6.4CM

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

b2cbe797-09a6-4c41-b6ab-fd70013a3c29

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Package DI Number

10857878007948

Quantity per Package

1

Contains DI Package

00857878007941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner