AMS 800 Artificial Urinary Sphincter

GUDID 00878953005652

Occlusive Cuff with InhibiZone

AMERICAN MEDICAL SYSTEMS, INC.

Urethral sphincter prosthesis system
Primary Device ID00878953005652
NIH Device Record Keyf2907a76-c8cf-4447-af06-31559e6717c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS 800 Artificial Urinary Sphincter
Version Model Number720157-01
Company DUNS125111448
Company NameAMERICAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter
Length3.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953005652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZYDevice, Incontinence, Mechanical/Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-13
Device Publish Date2014-09-24

On-Brand Devices [AMS 800 Artificial Urinary Sphincter]

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

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