Rear Tip Extender

GUDID 00878953004075

For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis

AMERICAN MEDICAL SYSTEMS, INC.

Penile prosthesis extender
Primary Device ID00878953004075
NIH Device Record Keyc8f35f69-39fc-4978-9261-560a641e6e97
Commercial Distribution StatusIn Commercial Distribution
Brand NameRear Tip Extender
Version Model Number72404323
Company DUNS125111448
Company NameAMERICAN MEDICAL SYSTEMS, INC.
Device Count2
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953004075 [Primary]
GS100878953009018 [Unit of Use]

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 Date2019-06-05
Device Publish Date2016-08-12

On-Brand Devices [Rear Tip Extender]

00878953004112For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004105For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004099For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004082For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004075For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004068For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004051For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004044For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.