Home GUDID 00850299008450 RIGI10
Primary DI 00850299008450
Brand RIGI10
Company Rigicon, Inc.
Model RG1011
Catalog number RG1011
Device description DIAMETER:11MM MALLEABLE PENILE PROSTHESIS
Published 2024-01-26
Public version status New
Distribution status 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 00850299008023 Previous GS1 0 00850299008450 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850299008023 00850299008023 850299008023 0850299008023 00850299008450 00850299008450 850299008450 0850299008450
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 Outer Diameter 11 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 32 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 045247683 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850033207811 RIGICON DILATOM™ 11-12 MM RSSC-1112 2024-06-26 00850033207828 RIGICON DILATOM™ 10-12 MM RSSC-1012 2024-06-26 00850033207842 RIGICON DILATOM™ 13-14 MM RSSC-1314 2024-06-26 00850033207873 RIGICON DILATOM™ 07-08 MM RSSC-0708 2024-06-26 00850033207880 RIGICON DILATOM™ 9-10 MM RSSC-0910 2024-06-26 00850015358289 Rigicon Stainless Steel Furlow Insertion Tool RSSF-1000 RSSF-1000 2024-02-02 00850015358296 Rigicon Stainless Steel Dilator 09-10 mm RSSD-0910 RSSD-0910 2024-02-02 00850015358302 Rigicon Stainless Steel Dilator 11-12 mm RSSD-1112 RSSD-1112 2024-02-02 00850015358319 Rigicon Stainless Steel Dilator 13-14 mm RSSD-1314 RSSD-1314 2024-02-02 00850015358326 Rigicon Stainless Steel Dilator 10-12 mm RSSD-1012 RSSD-1012 2024-02-02 00850015358395 Rigicon Furlow Insertion Tool RSUF-1000 RSUF-1000 2024-02-02 00850015358401 Rigicon HL Dilator 09 – 10 mm RSUD-0910 RSUD-0910 2024-02-02 00850015358418 Rigicon HL Dilator 11 – 12 mm RSUD-1112 RSUD-1112 2024-02-02 00850015358425 Rigicon HL Dilator 13 – 14 mm RSUD-1314 RSUD-1314 2024-02-02 00850015358432 Rigicon HL Dilator 15 – 16 mm RSUD-1516 RSUD-1516 2024-02-02 00850015358449 Rigicon HL Dilator 10 – 12 mm RSUD-1012 RSUD-1012 2024-02-02 00850015358746 RIGICON SURGICAL RETRACTOR RSRK-1000 RSRK-1000 2024-02-02 00850033207453 Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm RSSL-1012 RSSL-1012 2024-02-02 00850033207460 Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm RSSL-1014 RSSL-1014 2024-02-02 00850033207941 Rigicon Stainless Steel Dilator 15-16 mm RSSD-1516 2024-02-02
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 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 00878953005232 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
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