AMS 700 LG MS Pump

GUDID 00878953005782

Inflatable Penile Prosthesis, Preconnected - Infrapubic, 1 Pump, 2 Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis
Primary Device ID00878953005782
NIH Device Record Keya4835d4f-1b7f-47f3-aba7-04e9118b75d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS 700 LG MS Pump
Version Model Number72404308
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 Productfalse
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
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter
Length21 Centimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953005782 [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 Number5
Public Version Date2019-02-13
Device Publish Date2014-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

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00878953004051 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004068 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004075 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004082 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004099 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004105 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis

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