Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm RSSL-1012

GUDID 00850033207453

Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm

Rigicon, Inc.

Corpus cavernosum dilator, reusable

• Primary Device ID: 00850033207453
• NIH Device Record Key: 6d620d92-1fce-48b9-9faf-ae48895bcda7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm
• Version Model Number: RSSL-1012
• Catalog Number: RSSL-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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00850033207453 [Primary]

FDA Product Code

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

Sterilization

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

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00850033207453]

Ethylene Oxide;Moist Heat or Steam Sterilization

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

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• 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