Catalog Number

UF(II) 3810UV3

Brand Name

UV Active Implant System

Version/Model Number

UF(II) 3810UV3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K182194

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

b7514876-1f80-4b05-b76e-24171f5fae2f

Public Version Date

January 17, 2020

Public Version Number

1

DI Record Publish Date

January 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-