Swift Coil System

GUDID 00815948029675

SwiftPAC Coil, 20 cm

PENUMBRA, INC.

Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil

• Primary Device ID: 00815948029675
• NIH Device Record Key: 5bffd7ef-b954-48a8-b260-2be2cab8bd63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swift Coil System
• Version Model Number: 400SWPC20-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	00815948029675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230284

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR 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: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [Swift Coil System]

• 00815948029736: Swift Coil Detachment Handle
• 00815948029729: SwiftPAC Coil, 55 cm
• 00815948029712: SwiftPAC Coil, 50 cm
• 00815948029705: SwiftPAC Coil, 40 cm
• 00815948029699: SwiftPAC Coil, 35 cm
• 00815948029682: SwiftPAC Coil, 25 cm
• 00815948029675: SwiftPAC Coil, 20 cm
• 00815948029668: SwiftPAC Coil, 12 cm
• 00815948029651: SwiftPAC Coil, 9 cm
• 00815948029644: SwiftPAC Coil, 2 cm
• 00815948029637: SwiftPAC Coil, 1 cm
• 00815948029583: SwiftPAC Coil, 60 cm
• 00815948029576: SwiftPAC Coil, 45 cm
• 00815948029569: SwiftPAC Coil, 30 cm
• 00815948029552: SwiftPAC Coil, 15 cm
• 00815948029545: SwiftPAC Coil, 10 cm
• 00815948029538: SwiftPAC Coil, 8 cm
• 00815948029521: SwiftPAC Coil, 7 cm
• 00815948029514: SwiftPAC Coil, 6 cm
• 00815948029507: SwiftPAC Coil, 5 cm
• 00815948024793: SwiftPAC Coil, 4 cm
• 00815948024779: SwiftPAC Coil, 3 cm