Catalog Number

-

Brand Name

OSTEOPRECISION

Version/Model Number

GD-1215-150

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

K151543,K151543,K151543

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

7c06afea-c9e9-4ea0-b6e5-fe0f8a0f6194

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

20815634020454

Quantity per Package

1

Contains DI Package

10815634020457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHIP BOX