AMS 700 CX

GUDID 00878953003290

Inflatable Penile Prosthesis Cylinders with InhibiZone

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis
Primary Device ID00878953003290
NIH Device Record Keya4d999a2-5f7a-45d3-b36b-57f86b324a68
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS 700 CX
Version Model Number72404175
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

Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter
Length24 Centimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953003290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCWProsthesis, Penis, Inflatable

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 Date2014-09-25

On-Brand Devices [AMS 700 CX ]

00878953003825Inflatable Penile Prosthesis Cylinders, 2 Cylinders
00878953003818Inflatable Penile Prosthesis Cylinders, 2 Cylinders
00878953003801Inflatable Penile Prosthesis Cylinders, 2 Cylinders
00878953003795Inflatable Penile Prosthesis Cylinders, 2 Cylinders
00878953003788Inflatable Penile Prosthesis Cylinders
00878953003290Inflatable Penile Prosthesis Cylinders with InhibiZone
00878953003283Inflatable Penile Prosthesis Cylinders with InhibiZone
00878953003276Inflatable Penile Prosthesis Cylinders with InhibiZone
00878953003269Inflatable Penile Prosthesis Cylinders with InhibiZone
00878953003252Inflatable Penile Prosthesis Cylinders with InhibiZone

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