Catalog Number

-

Brand Name

PLEXUR P®

Version/Model Number

60000525

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2017

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

FDA Premarket Submission

K080511

Product Code

MBP

Product Code Name

Filler, bone void, osteoinduction (w/o human growth factor)

Public Device Record Key

64596ca0-29fc-4e60-99b5-81f5a074f79a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-