RIGICON DILATOM™ RSSC-1012

GUDID 00850033207828

Rigicon, Inc.

Corpus cavernosum dilator, reusable

• Primary Device ID: 00850033207828
• NIH Device Record Key: 90672175-643f-446e-a230-475b89a320a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGICON DILATOM™
• Version Model Number: 10-12 MM
• Catalog Number: RSSC-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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033207828 [Primary]

FDA Product Code

• QGA: Penile Implant Surgical Accessories

Sterilization

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

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

[00850033207828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [RIGICON DILATOM™]

• 00850033207880: 9-10 MM
• 00850033207873: 07-08 MM
• 00850033207842: 13-14 MM
• 00850033207828: 10-12 MM
• 00850033207811: 11-12 MM