Catalog Number

-

Brand Name

OsteoGen Pre-Filled Syringe - 0.3g / 0.6cc

Version/Model Number

OG-SYR

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

c93af55a-5449-4d84-b4fe-dba6174fca20

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 27, 2015

Package DI Number

00855286006099

Quantity per Package

6

Contains DI Package

00855286006082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-