Catalog Number

OF-0348/A

Brand Name

Osseoflex®

Version/Model Number

00884450327944

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

KIH

Product Code Name

DISPENSER, CEMENT

Public Device Record Key

a5b73011-5fcb-4538-84f7-e9bbe74f915c

Public Version Date

March 22, 2019

Public Version Number

2

DI Record Publish Date

March 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-