Catalog Number

720127-01

Brand Name

Elevate

Version/Model Number

720127-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 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

OTP

Product Code Name

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Public Device Record Key

4897f0f6-ddbf-4cad-ba01-831b387de368

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-