Rigicon HL Dilator 10 – 12 mm RSUD-1012

GUDID 00850015358449

Rigicon HL Dilator 10 – 12 mm Disposable

Rigicon, Inc.

Penile prosthesis implantation instrument

• Primary Device ID: 00850015358449
• NIH Device Record Key: 3fd1decc-d712-4e3c-be89-8efb84b10993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rigicon HL Dilator 10 – 12 mm
• Version Model Number: RSUD-1012
• Catalog Number: RSUD-1012
• Company DUNS: 045247683
• Company Name: Rigicon, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015358449 [Primary]

FDA Product Code

• KOA: Surgical Instruments, G-U, Manual (And Accessories)

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: 2024-02-12
• Device Publish Date: 2024-02-02

Devices Manufactured by Rigicon, Inc.

• 00850033207811 - RIGICON DILATOM™: 2024-07-04
• 00850033207828 - RIGICON DILATOM™: 2024-07-04
• 00850033207842 - RIGICON DILATOM™: 2024-07-04
• 00850033207873 - RIGICON DILATOM™: 2024-07-04
• 00850033207880 - RIGICON DILATOM™: 2024-07-04
• 00850015358289 - Rigicon Stainless Steel Furlow Insertion Tool: 2024-02-12 Rigicon Stainless Steel Furlow Insertion Tool
• 00850015358296 - Rigicon Stainless Steel Dilator 09-10 mm: 2024-02-12 Rigicon Stainless Steel Dilator 09-10 mm
• 00850015358302 - Rigicon Stainless Steel Dilator 11-12 mm: 2024-02-12 Rigicon Stainless Steel Dilator 11-12 mm