Catalog Number

UF(II) 5013SF

Brand Name

UF(II) Implant System

Version/Model Number

UF(II) 5013SF

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

K170608

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

e20731a7-13db-4aae-98d7-1d3594c281cc

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-