Minima Stent System - 8mm

GUDID 00196852805037

Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.

RENATA MEDICAL, INC.

Bare-metal aortic stent

• Primary Device ID: 00196852805037
• NIH Device Record Key: ae5d9544-9118-45a1-8208-38412f7919ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minima Stent System - 8mm
• Version Model Number: FG-0002
• Company DUNS: 084169964
• Company Name: RENATA MEDICAL, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852805037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240003

FDA Product Code

• PNF: Aortic Stent

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: 2025-04-10
• Device Publish Date: 2025-04-02

Devices Manufactured by RENATA MEDICAL, INC.

• 00196852801862 - Minima Stent System - 6mm: 2025-04-10 Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
• 00196852805037 - Minima Stent System - 8mm: 2025-04-10Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
• 00196852805037 - Minima Stent System - 8mm: 2025-04-10 Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.