Pounce™ Venous Thrombectomy System

GUDID 00812339030302

Pounce Venous Thrombectomy System

Surmodics, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00812339030302
• NIH Device Record Key: 62f10dbf-e37c-47dc-8d9b-ba625715b76a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pounce™ Venous Thrombectomy System
• Version Model Number: VTS-1018-09010
• Company DUNS: 098414659
• Company Name: Surmodics, 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812339030302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201705

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Pounce™ Venous Thrombectomy System]

• 00812339030302: Pounce Venous Thrombectomy System
• 00812339030791: Pounce Venous Thrombectomy System