RIGI10™ RG1013

GUDID 00850299008047

Malleable Penile Prosthesis

RIGICON, INC.

Rigid penile prosthesis
Primary Device ID00850299008047
NIH Device Record Key063c06aa-7e95-4920-a534-147b55d98be0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGI10™
Version Model NumberRG1013
Catalog NumberRG1013
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 Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
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Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850299008047 [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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