Catalog Number

-

Brand Name

EXTERNA® UNIVERSAL PLUS PLATFORM IMPLANT Ø4,5 ↕11,5

Version/Model Number

IRPS4511

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 13, 2017

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

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

K022258

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

1d3da6ff-99b3-4a77-abf2-470390136c93

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-