AMS 800 Artificial Urinary Sphincter

Basic Information

• Brand Name: AMS 800 Artificial Urinary Sphincter
• Primary DI: 00878953004938
• Version / Model: 720066-01
• 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: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 8c03f9bc-1736-4be3-a588-80f328974c00

Device Description

Accessory Kit Quick Connect Window Connectors (3 Straight, 2 Right Angle, 1 Y), Suture-Tie Connectors (3 Straight, 2 Right Angle, 1 Y), 8 Collets, 1 Collet Holder, 1 Cuff Sizer, 2 22-Gauge Blunt Tip Needles, 2 15-Gauge Blunt Tip Needles, 2 30 cm Lengths of Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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	00878953004938	GS1