Catalog Number

9045-02

Brand Name

PERPOS PLS SYSTEM, Dual Implant

Version/Model Number

9045-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 2016

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MRW

Product Code Name

System, Facet Screw Spinal Device

Public Device Record Key

a2b62f07-ebee-42b7-b4aa-95dab33ec531

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-