Catalog Number

-

Brand Name

Desara

Version/Model Number

CAL-DS01

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

K101169,K101169,K101169

Product Code

OTN

Product Code Name

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Public Device Record Key

db9aa2bd-d8d1-47e2-9512-668978fed793

Public Version Date

July 19, 2022

Public Version Number

7

DI Record Publish Date

October 30, 2015

Package DI Number

00890594000049

Quantity per Package

5

Contains DI Package

00890594000629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box