Home GUDID 00878953005409 Spectra RTE Kit
Primary DI 00878953005409
Brand Spectra RTE Kit
Company AMERICAN MEDICAL SYSTEMS, INC.
Model 720171-01
Device description Rear Tip Extender Kit 2 Each - 4.0 cm, 5.0 cm, 6.0 cm
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 00878953005409 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 00878953005409 00878953005409 878953005409 0878953005409
GMDN Terms# Term, Definition table Term Definition Penile prosthesis extender A sterile implantable device intended to extend the cylinder component of a penile prosthesis to achieve an overall cylinder length which fits the measurements of the patient's anatomy (i.e., corpora cavernosa length). It is a synthetic polymer (e.g., silicone) moulded cap available in a variety of sizes and is intended to be attached to the end of a penile prosthesis cylinder during implantation, in cases where the cylinder is of insufficient length.
Device Sizes# Type, Value, Unit table Type Value Unit Length 4 Centimeter Length 5 Centimeter Length 6 Centimeter Outer Diameter 9.5 Millimeter
Regulatory Flags# DUNS number 125111448 Device count 1 Kit true 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 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