Catalog Number

-

Brand Name

Desara One

Version/Model Number

CAL-DS2111

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

K191416,K191416

Product Code

PAH

Product Code Name

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Public Device Record Key

dd034f73-2acb-4f40-b1da-7828f505ae26

Public Version Date

July 19, 2022

Public Version Number

4

DI Record Publish Date

February 25, 2020

Package DI Number

00890594000964

Quantity per Package

1

Contains DI Package

00890594000957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box