WOLF Thrombectomy Sheath, 14F

GUDID 00850029546153

WOLF Thrombectomy Sheath, 14F - 75cm, Curved

Devoro Medical Inc.

Thrombectomy suction catheter

• Primary Device ID: 00850029546153
• NIH Device Record Key: 46925bec-492c-4bef-9a43-3434a20a1458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOLF Thrombectomy Sheath, 14F
• Version Model Number: FD0381-13
• Company DUNS: 117672411
• Company Name: Devoro Medical 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850029546153 [Primary]

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: 2023-07-20
• Device Publish Date: 2023-07-12

Devices Manufactured by Devoro Medical Inc.

• 00191506050016 - SmartClaw™: 2024-06-13 Thrombectomy Catheter
• 00191506050023 - SmartClaw™: 2024-06-13 Thrombectomy Catheter
• 00850029546009 - WOLF Thrombectomy SmartClaw Catheter: 2023-07-20 WOLF Thrombectomy SmartClaw Catheter, 20mm
• 00850029546023 - WOLF Thrombectomy System, 14F: 2023-07-20 WOLF Thrombectomy System, 14F - 6mm Funnel x 110cm
• 00850029546030 - WOLF Thrombectomy System, 14F: 2023-07-20 WOLF Thrombectomy System, 14F - 8mm Funnel x 110cm
• 00850029546047 - WOLF Thrombectomy System, 14F: 2023-07-20 WOLF Thrombectomy System, 14F - 10mm Funnel x 110cm
• 00850029546054 - WOLF Thrombectomy System, 14F: 2023-07-20 WOLF Thrombectomy System, 14F - 12mm Funnel x 110cm
• 00850029546115 - WOLF Thrombectomy Reload Pack, 14F: 2023-07-20 WOLF Thrombectomy Reload Pack, 14F - 110cm