RIGI10™ RG1010

GUDID 00850299008016

Malleable Penile Prosthesis

RIGICON, INC.

Rigid penile prosthesis

• Primary Device ID: 00850299008016
• NIH Device Record Key: b2deda3a-9346-4527-8962-687ab46c1a55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGI10™
• Version Model Number: RG1010
• Catalog Number: RG1010
• 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: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com
• Phone: 888 202 9790
• Email: operations@rigicon.com

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
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• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850299008016 [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: 2019-12-20
• Device Publish Date: 2019-12-12

On-Brand Devices [RIGI10™]

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