Wolverine Coronary Cutting Balloon H74939402153250

GUDID 08714729888093

Microsurgical Dilatation Device

BOSTON SCIENTIFIC CORPORATION

Coronary angioplasty balloon catheter, cutting/scoring

• Primary Device ID: 08714729888093
• NIH Device Record Key: 59ed1369-3faa-4809-8067-32ca334abb7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wolverine Coronary Cutting Balloon
• Version Model Number: H74939402153250
• Catalog Number: H74939402153250
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729888093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950020

FDA Product Code

• NWX: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

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: 2022-05-13
• Device Publish Date: 2017-11-22

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