AngioJet® Spiroflex® 106553

GUDID 08714729889380

Thrombectomy Set

BOSTON SCIENTIFIC CORPORATION

Thrombectomy suction catheter

• Primary Device ID: 08714729889380
• NIH Device Record Key: f3fc2733-27e3-4fd5-a2d9-00c85df9f760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioJet® Spiroflex®
• Version Model Number: 106553-001
• Catalog Number: 106553
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729889380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980037

FDA Product Code

• MCX: CATHETER, CORONARY, ATHERECTOMY

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: 2022-08-05
• Device Publish Date: 2015-04-21

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729877769 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877776 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877783 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877806 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877813 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877820 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877837 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter
• 08714729877844 - Orbiter™ ST: 2024-12-20 Bidirectional Steerable Diagnostic Catheter