Catalog Number

BRD500HL

Brand Name

Align® TO Trans-Obturator Urethral Support System - Halo

Version/Model Number

BRD500HL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2016

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

OTN

Product Code Name

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

Public Device Record Key

d1f587d9-c07b-49bf-b360-0770a19589ae

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2015

Package DI Number

10801741016223

Quantity per Package

1

Contains DI Package

00801741016226

Package Discontinue Date

December 31, 2016

Package Status

Not in Commercial Distribution

Package Type

Other