Pounce Sheath

GUDID 00812339030753

Surmodics, Inc.

Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath 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

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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.

• 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
• 00812339030364 - SurVeil DCB: 2023-10-12 SurVeil DCB 4.0mm x 100mm x 135cm
• 00812339030371 - SurVeil DCB: 2023-10-12 SurVeil DCB 4.0mm x 120mm x 135cm