Catalog Number

54500277O18

Brand Name

Simplant

Version/Model Number

Version 18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2019

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

-

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

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

4035d386-a538-4976-a1a1-b88cde6551f8

Public Version Date

August 26, 2019

Public Version Number

4

DI Record Publish Date

May 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-