Catalog Number

-

Brand Name

ALLOGENIX

Version/Model Number

02-3102

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXP

Product Code Name

Methyl Methacrylate For Cranioplasty

Public Device Record Key

0aa1cf8f-4d85-483f-9d01-8e9a579b314d

Public Version Date

July 29, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-