Catalog Number

-

Brand Name

Solyx™ Blue

Version/Model Number

M0068507010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

PAH

Product Code Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Public Device Record Key

9d310a8f-d90a-4f13-9c71-08285af4f10b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

June 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-