Catalog Number

-

Brand Name

OSTEOXPRESS

Version/Model Number

GD-5515

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2021

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

K151543,K151543

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

e04212db-db40-42fb-883b-f05296bd9c5e

Public Version Date

March 31, 2021

Public Version Number

4

DI Record Publish Date

January 13, 2017

Package DI Number

10815634020464

Quantity per Package

5

Contains DI Package

00815634020467

Package Discontinue Date

March 30, 2021

Package Status

Not in Commercial Distribution

Package Type

SHELF BOX