Catalog Number

OF-0222/B

Brand Name

Osseoflex®

Version/Model Number

00884450386750

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

K141930,K141930

Product Code

NDN

Product Code Name

CEMENT, BONE, VERTEBROPLASTY

Public Device Record Key

f22fb6fa-5e35-4aeb-83f5-c163412178dd

Public Version Date

July 02, 2019

Public Version Number

1

DI Record Publish Date

June 24, 2019

Package DI Number

10884450386757

Quantity per Package

1

Contains DI Package

00884450386750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-