Catalog Number

720163-03

Brand Name

AdVance™ XP

Version/Model Number

720163-03

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

OTM

Product Code Name

Mesh, surgical, for stress urinary incontinence, male

Public Device Record Key

604cc6a9-9a75-4588-b560-1d23f79b5d73

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-