Catalog Number

UNSCA 40204N

Brand Name

UF(II) Narrow Implant System

Version/Model Number

UNSCA 40204N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2022

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

K161987

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

6b35f9cd-19d3-4255-86d9-25b056d0b9d2

Public Version Date

February 24, 2022

Public Version Number

3

DI Record Publish Date

August 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-