AMS Ambicor RTE Kit

GUDID 00878953001364

Rear Tip Extenders 8 (2 each: 0.5, 1, 2, 3 cm)

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis
Primary Device ID00878953001364
NIH Device Record Key96486944-b818-4585-86fd-f1b8ba251946
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS Ambicor RTE Kit
Version Model Number72402890
Company DUNS125111448
Company NameAMERICAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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

Length0.5 Centimeter
Length0.5 Centimeter
Length0.5 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter
Length3 Centimeter
Length2 Centimeter
Length1 Centimeter
Length0.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953001364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FHWDevice, Impotence, 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

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

00878953002774 - AMS 700 CXR RTE Kit2019-10-11 Rear Tip Extender Kit, 2 Each 4.0 cm, 5.0 cm, 6.0 cm
00878953004044 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
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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