Home GUDID 00878953005232 Spectra
Primary DI 00878953005232
Brand Spectra
Company AMERICAN MEDICAL SYSTEMS, INC.
Model 720056-01
Device description Concealable Penile Prosthesis, 2 Cylinders
Published 2016-08-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FAE Prosthesis, Penile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAE Prosthesis, Penile Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00878953005232 Primary GS1 0 00878953008950 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00878953005232 00878953005232 878953005232 0878953005232 00878953008950 00878953008950 878953008950 0878953008950
GMDN Terms# Term, Definition table Term Definition Rigid penile prosthesis A rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing.
Device Sizes# Type, Value, Unit table Type Value Unit Length 12 Centimeter Outer Diameter 14 Millimeter
Regulatory Flags# DUNS number 125111448 Device count 2 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850299008443 RIGI10 Rigicon, Inc. FAE 2024-01-26 00850299008450 RIGI10 Rigicon, Inc. FAE 2024-01-26 00850299008467 RIGI10 Rigicon, Inc. FAE 2024-01-26 00850299008474 RIGI10 Rigicon, Inc. FAE 2024-01-26 00850299008481 RIGI10 Rigicon, Inc. FAE 2024-01-26 00850299008009 RIGI10™ Rigicon, Inc. FAE 2019-12-12 00850299008016 RIGI10™ Rigicon, Inc. FAE 2019-12-12 00850299008023 RIGI10™ Rigicon, Inc. FAE 2019-12-12 00850299008030 RIGI10™ Rigicon, Inc. FAE 2019-12-12 00850299008047 RIGI10™ Rigicon, Inc. FAE 2019-12-12 08714729979340 TACTRA BOSTON SCIENTIFIC CORPORATION FAE 2019-05-06 08714729979357 TACTRA BOSTON SCIENTIFIC CORPORATION FAE 2019-05-06 08714729979364 TACTRA BOSTON SCIENTIFIC CORPORATION FAE 2019-05-06 00878953000497 Sizer AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-09-24 00878953000503 Sizer AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-09-24 00878953004044 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004051 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004068 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004075 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004082 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004099 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004105 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953004112 Rear Tip Extender BOSTON SCIENTIFIC CORPORATION FAE 2016-08-12 00878953005201 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12 00878953005218 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12 00878953005225 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12 00878953005249 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12 00878953005256 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12 00878953005270 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12 00878953005287 Spectra AMERICAN MEDICAL SYSTEMS, INC. FAE 2016-08-12