OptiCross 35 H7493932800350

GUDID 08714729984542

Peripheral Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 08714729984542
• NIH Device Record Key: 5e5222ad-5403-428c-9b6d-ad76e39cb12a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiCross 35
• Version Model Number: H7493932800350
• Catalog Number: H7493932800350
• 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: true
• 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 Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729984542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200733

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2020-06-23
• Device Publish Date: 2020-06-15

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