Catalog Number

51153

Brand Name

Neoss Implant System

Version/Model Number

51153

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2021

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

5354f27d-8e54-4874-80ac-48798d68c8a1

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

October 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-