Catalog Number

380-2507

Brand Name

Rampart-O

Version/Model Number

10-10-41-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 18, 2015

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

97c81566-6fd1-49e7-81d1-070798276243

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-