Catalog Number

RP6

Brand Name

ReOss

Version/Model Number

RP6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K082419

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

7ad2be61-7ef3-4932-ab6d-fc82da601559

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-