Catalog Number

-

Brand Name

Desara Blue

Version/Model Number

CAL-DS01B

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

K132069,K132069,K132069

Product Code

OTO

Product Code Name

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

Public Device Record Key

b2b6c828-2727-45c7-99ab-d865a3974fa9

Public Version Date

July 19, 2022

Public Version Number

7

DI Record Publish Date

May 26, 2016

Package DI Number

00890594000650

Quantity per Package

5

Contains DI Package

00890594000674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box