Catalog Number

M0068502060

Brand Name

Advantage Ultra System

Version/Model Number

M0068502060

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

OTN

Product Code Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

Public Device Record Key

82dc5bff-c86a-440d-98ff-056e559cbf57

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-