Ruby XL Coil System

GUDID 00810169721728

POD XL, 8mm x 55cm

PENUMBRA, INC.

Non-neurovascular embolization coil

• Primary Device ID: 00810169721728
• NIH Device Record Key: 65904b12-4d12-499e-a111-57d2c2188954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ruby XL Coil System
• Version Model Number: RBYPODXL0855-A
• Company DUNS: 191077671
• Company Name: PENUMBRA, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810169721728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250079

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [Ruby XL Coil System]

• 00810169721773: POD XL, 16mm x 55cm
• 00810169721766: POD XL, 14mm x 55cm
• 00810169721759: POD XL, 12mm x 55cm
• 00810169721742: POD XL, 10mm x 55cm
• 00810169721735: POD XL, 8mm x 70cm
• 00810169721728: POD XL, 8mm x 55cm
• 00810169721711: POD XL, 6mm x 55cm
• 00810169721704: POD XL, 6mm x 20cm
• 00810169721698: POD XL, 5mm x 30cm
• 00810169721681: POD XL, 5mm x 10cm
• 00810169721674: POD XL, 4mm x 30cm
• 00810169721667: POD XL, 4mm x 10cm
• 00810169721650: Ruby Coil XL, 40mm x 70cm
• 00810169721643: Ruby Coil XL, 40mm x 55cm
• 00810169721636: Ruby Coil XL, 32mm x 55cm
• 00810169721629: Ruby Coil XL, 28mm x 55cm
• 00810169721612: Ruby Coil XL, 24mm x 55cm
• 00810169721605: Ruby Coil XL, 20mm x 55cm
• 00810169721599: Packing Coil XL, 70cm
• 00810169721582: Packing Coil XL, 55cm
• 00810169721575: Packing Coil XL, 45cm
• 00810169721568: Packing Coil XL, 30cm
• 00810169721551: Packing Coil XL, 15cm