Catalog Number

UF(II) 7008SF

Brand Name

UF(II) Wide

Version/Model Number

UF(II) 7008SF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173975

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

1cefb777-3acf-4c33-9844-84fe3d4dc95e

Public Version Date

February 28, 2022

Public Version Number

3

DI Record Publish Date

August 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-