Catalog Number

-

Brand Name

AMS 800 Artificial Urinary Sphincter

Version/Model Number

72400026

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

EZY

Product Code Name

Device, Incontinence, Mechanical/Hydraulic

Public Device Record Key

440a3861-125d-44e6-9030-a64cd8e82d7d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-