AMS 800 Artificial Urinary Sphincter

Basic Information

• Brand Name: AMS 800 Artificial Urinary Sphincter
• Primary DI: 00878953000725
• Version / Model: 72400161
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 125111448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6447cd74-2269-48c0-a9b8-a2695308d318

Device Description

Occlusive Cuff

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZY	Device, Incontinence, Mechanical/Hydraulic	Gastroenterology, Urology	876.5280	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35280	Urethral sphincter prosthesis, non-powered	An implantable assembly of non-electric devices intended to support or replace a natural urethral sphincter for the management of incontinence. It is a hydraulically-operated system typically consisting of a cuff to surround the urethra, a reservoir for the hydraulic liquid (e.g., saline with/without radiopacifier), and a manually driven pump.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878953000725	GS1

Device Sizes

Type	Value	Unit	Text
Length	4.5	Centimeter