Catalog Number

GPSL

Brand Name

GYNECARE GYNEMESH

Version/Model Number

GPSL

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

K013718

Product Code

OTO

Product Code Name

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

Public Device Record Key

d6913ef9-baea-4344-8bd4-7cbc341a1637

Public Version Date

January 13, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-