Systems Configuration

GUDID 00815948020061

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00815948020061
• NIH Device Record Key: 12b24dae-99d5-4640-ae59-602a4fff8976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Systems Configuration
• Version Model Number: ACE603DVELSYS-A
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948020061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113163

FDA Product Code

• NRY: Catheter, Thrombus Retriever

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-01-26

Devices Manufactured by PENUMBRA, INC.

• 00810169722480 - Indigo System Lightning Bolt 16: 2025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Select+ 135cm H1 Tip
• 00810169722497 - Indigo System Lightning Bolt 16: 2025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Select+ 120cm H1 Tip
• 00810169722503 - Indigo System Lightning Bolt 16: 2025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+ 120cm H1 Tip
• 00810169722510 - Indigo System Lightning Bolt 16: 2025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip
• 00810169722527 - Indigo System Lightning Flash: 2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Select+ 135cm H1 Tip
• 00810169722534 - Indigo System Lightning Flash: 2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Select+ 120cm H1 Tip
• 00810169722541 - Indigo System Lightning Flash: 2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+ 120cm H1 Tip
• 00810169722558 - Indigo System Lightning Flash: 2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip