Catalog Number

-

Brand Name

OSTEOPRECISION

Version/Model Number

GD-1015-100

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

b79d5b9e-69fe-469f-a903-2bea67564aeb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2016

Package DI Number

10815634020389

Quantity per Package

5

Contains DI Package

00815634020382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHELF BOX