Catalog Number

-

Brand Name

Athena Surgical RMUS System

Version/Model Number

9002-1

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

K210087,K210087,K210087

Product Code

OTN

Product Code Name

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Public Device Record Key

3edab67f-fd52-40cd-975a-bce074daa542

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

July 30, 2021

Package DI Number

10860003619824

Quantity per Package

3

Contains DI Package

00860003619827

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-