AngioJet® Spiroflex® 106553

GUDID 08714729889380

Thrombectomy Set

BOSTON SCIENTIFIC CORPORATION

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter 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

• 08714729042549 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729042570 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042587 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042594 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042600 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729154921 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729154969 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729191872 - Passport: 2024-04-05 Balloon Dilatation Catheter