Catalog Number

ARTY

Brand Name

ARTISYN

Version/Model Number

ARTY

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

-

Product Code

OTO

Product Code Name

Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Public Device Record Key

80c0b430-e406-420c-91d7-8ac059d37c19

Public Version Date

November 25, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-