Catalog Number

Y500

Brand Name

Alyte™ Y-Mesh Graft

Version/Model Number

Y500

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

OTO

Product Code Name

Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Public Device Record Key

8ad752f1-a241-4c72-964c-ab26307ef2ba

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2015

Package DI Number

10801741016162

Quantity per Package

5

Contains DI Package

00801741016165

Package Discontinue Date

December 31, 2016

Package Status

Not in Commercial Distribution

Package Type

CA