Pounce Sheath

GUDID 00812339030753

Surmodics, Inc.

Cardiovascular catheter sheath

• Primary Device ID: 00812339030753
• NIH Device Record Key: c346c495-7269-4d78-bb93-555cfcf1e892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pounce Sheath
• Version Model Number: PSF-0035-12F14
• 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: 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00812339030753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231828

FDA Product Code

• DYB: Introducer, Catheter

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: 2023-09-29
• Device Publish Date: 2023-09-21

Devices Manufactured by Surmodics, Inc.

• 00812339030807 - Pounce ™ XL Thrombectomy: 2024-11-21 Pounce XL Arterial Thrombectomy Sytem
• 00812339030326 - Pounce ™ Thrombectomy: 2024-10-28 Pounce Arterial Thrombectomy System with Handle
• 00812339030791 - Pounce™ Venous Thrombectomy System: 2024-06-17 Pounce Venous Thrombectomy System
• 00812339030760 - Pounce ™ LP Thrombectomy: 2024-03-27 Pounce LP Thrombectomy System
• 00812339030319 - Pounce Venous Thrombectomy System: 2023-11-06 Pounce Venous Thrombectomy System
• 00812339030333 - SurVeil DCB: 2023-10-12 SurVeil DCB 4.0mm x 40mm x 135cm
• 00812339030340 - SurVeil DCB: 2023-10-12 SurVeil DCB 4.0mm x 60mm x 135cm
• 00812339030357 - SurVeil DCB: 2023-10-12 SurVeil DCB 4.0mm x 80mm x 135cm