AMS 700 CXR MS Pump

GUDID 00878953003702

Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis
Primary Device ID00878953003702
NIH Device Record Keyc8dbd966-c129-41ad-a9fd-ba58e75c0c1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS 700 CXR MS Pump
Version Model Number72404262
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 Diameter9.5 Millimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter
Length14 Centimeter
Outer Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953003702 [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 CXR MS Pump]

00878953003771Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump 2 C
00878953003764Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic, 1 Pump, 2
00878953003757Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump 2 C
00878953003740Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic, 1 Pump 2 Cy
00878953003733Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump 2 C
00878953003726Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
00878953003719Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
00878953003702Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
00878953003696Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
00878953003689Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders

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