RIGI10 RG1010

GUDID 00850299008467

DIAMETER:10MM MALLEABLE PENILE PROSTHESIS

Rigicon, Inc.

Rigid penile prosthesis
Primary Device ID00850299008467
NIH Device Record Key4c8995b7-e00f-47f0-ac08-f367abce8b1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGI10
Version Model NumberRG1010
Catalog NumberRG1010
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

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850299008016 [Previous]
GS100850299008467 [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 Date2024-02-05
Device Publish Date2024-01-26

On-Brand Devices [RIGI10 ]

00850299008481DIAMETER:13MM MALLEABLE PENILE PROSTHESIS
00850299008474DIAMETER:12MM MALLEABLE PENILE PROSTHESIS
00850299008467DIAMETER:10MM MALLEABLE PENILE PROSTHESIS
00850299008450DIAMETER:11MM MALLEABLE PENILE PROSTHESIS
00850299008443DIAMETER:9MM MALLEABLE PENILE PROSTHESIS

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