AMS 800 Artificial Urinary Sphincter

GUDID 00878953005461

Occlusive Cuff

AMERICAN MEDICAL SYSTEMS, INC.

Urethral sphincter prosthesis system

• Primary Device ID: 00878953005461
• NIH Device Record Key: 38872512-318b-4268-add0-cec3aa32ef91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 800 Artificial Urinary Sphincter
• Version Model Number: 720133-01
• Company DUNS: 125111448
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000053

FDA Product Code

• EZY: Device, Incontinence, Mechanical/Hydraulic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2014-09-24

On-Brand Devices [AMS 800 Artificial Urinary Sphincter]

• 00878953005652: Occlusive Cuff with InhibiZone
• 00878953005461: Occlusive Cuff
• 00878953004938: Accessory Kit Quick Connect Window Connectors (3 Straight, 2 Right Angle, 1 Y), Suture-Tie Co
• 00878953003191: Occlusive Cuff with InhibiZone
• 00878953003184: Occlusive Cuff with InhibiZone
• 00878953003177: Occlusive Cuff with InhibiZone
• 00878953003160: Occlusive Cuff with InhibiZone
• 00878953003153: Occlusive Cuff with InhibiZone
• 00878953003146: Occlusive Cuff with InhibiZone
• 00878953003139: Occlusive Cuff with InhibiZone
• 00878953003122: Occlusive Cuff with InhibiZone
• 00878953003115: Occlusive Cuff with InhibiZone
• 00878953003108: Occlusive Cuff with InhibiZone
• 00878953003092: Occlusive Cuff with InhibiZone
• 00878953003085: Occlusive Cuff with InhibiZone
• 00878953003078: Control Pump with InhibiZone
• 00878953001036: Accessory Kit: Quick Connect Window Connectors (3 Straight, 2 Right Angle, 1Y), Suture-Tie Conn
• 00878953000824: Occlusive Cuff
• 00878953000817: Occlusive Cuff
• 00878953000800: Occlusive Cuff
• 00878953000794: Occlusive Cuff
• 00878953000787: Occlusive Cuff
• 00878953000770: Occlusive Cuff
• 00878953000763: Occlusive Cuff
• 00878953000756: Occlusive Cuff
• 00878953000749: Occlusive Cuff
• 00878953000732: Occlusive Cuff
• 00878953000725: Occlusive Cuff
• 00878953000718: Occlusive Cuff
• 00878953000688: Control Pump
• 00878953000657: Pressure Regulating Balloon, Pressure: 91-100 cm H20
• 00878953000640: Pressure Regulating Balloon, Pressure: 81-90 cm H20
• 00878953000633: Pressure Regulating Balloon, Pressure: 71-80 cm H20
• 00878953000626: Pressure Regulating Balloon, Pressure: 61-70 cm H20
• 00878953000619: Pressure Regulating Balloon, Pressure: 51-60 cm H20
• 00878953000602: Pressure Regulating Balloon, Pressure: 41-50 cm H20