RIGICON DILATOM™

Basic Information

• Brand Name: RIGICON DILATOM™
• Primary DI: 00850033207880
• Version / Model: 9-10 MM
• Catalog Number: RSSC-0910
• Company Name: Rigicon, Inc.
• Labeler DUNS: 045247683
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-26
• Public Version: 1
• Public Version Date: 2024-07-04
• Public Version Status: New
• Public Device Record Key: 0967403d-5204-4c77-ab63-a8eb7e3bf9a3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	876.3500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60171	Corpus cavernosum dilator, reusable	A non-sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of metal (e.g., stainless steel); it is available in a set of graduated sizes that are applied in succession. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033207880	GS1