Catalog Number

UMR3

Brand Name

ULTRAPRO

Version/Model Number

UMR3

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

-

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

9a45bab2-deb1-4955-a55a-c59d460154cb

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

20705031085920

Quantity per Package

3

Contains DI Package

10705031085923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX