RIGI10 RG1011

GUDID 00850299008450

DIAMETER:11MM MALLEABLE PENILE PROSTHESIS

Rigicon, Inc.

Rigid penile prosthesis

• Primary Device ID: 00850299008450
• NIH Device Record Key: ab2febe5-975b-438f-bbdb-4af0deb0bad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGI10
• Version Model Number: RG1011
• Catalog Number: RG1011
• Company DUNS: 045247683
• Company Name: Rigicon, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com
• Phone: 8882029790
• Email: operations@rigicon.com

Device Dimensions

• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850299008023 [Previous]
GS1	00850299008450 [Primary]

FDA Product Code

• FAE: Prosthesis, Penile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-05
• Device Publish Date: 2024-01-26

On-Brand Devices [RIGI10]

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