Catalog Number

11-001340

Brand Name

UMA Insert-IMZ 3.3-4.0mm

Version/Model Number

11-001340

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

K863680

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

c907ed8c-c5f2-43c0-bd50-82f2ca0754e1

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-