RIGI10™ RG1011

GUDID 00850299008023

Malleable Penile Prosthesis

RIGICON, INC.

Rigid penile prosthesis
Primary Device ID00850299008023
NIH Device Record Key35b0d35a-4372-4854-b47b-be74b3739b8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGI10™
Version Model NumberRG1011
Catalog NumberRG1011
Company DUNS045247683
Company NameRIGICON, INC.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com
Phone8882029790
Emailoperations@rigicon.com

Device Dimensions

Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
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Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850299008023 [Primary]

FDA Product Code

FAEProsthesis, Penile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-20
Device Publish Date2019-12-12

On-Brand Devices [RIGI10™]

00850299008047Malleable Penile Prosthesis
00850299008030Malleable Penile Prosthesis
00850299008023Malleable Penile Prosthesis
00850299008016Malleable Penile Prosthesis
00850299008009Malleable Penile Prosthesis

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