Catalog Number

-

Brand Name

Remeex System - Passer Handle

Version/Model Number

AR-05

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

-

Prescription Use (Rx)

-

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

8a4c6d79-37d2-4c13-be70-3b129a6b9c7b

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-