Catalog Number

-

Brand Name

Vertessa Lite Y-Mesh 26x4x3cm

Version/Model Number

CAL-VLY2643

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

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

K150023,K150023,K150023

Product Code

OTO

Product Code Name

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Public Device Record Key

396c8a8e-5769-44c6-8934-dd595b81c6f4

Public Version Date

July 19, 2022

Public Version Number

6

DI Record Publish Date

October 30, 2015

Package DI Number

00890594000469

Quantity per Package

3

Contains DI Package

00890594000483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX