RotaWire™ Drive and wireClip™ Torquer H74939463001

GUDID 08714729996248

Guidewire and Guidewire Manipulation Device

BOSTON SCIENTIFIC CORPORATION

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 08714729996248
• NIH Device Record Key: cbcf3f02-0227-4035-8754-5b14418d912e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RotaWire™ Drive and wireClip™ Torquer
• Version Model Number: H74939463001
• Catalog Number: H74939463001
• 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 Dimensions

• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch
• Guidewire Length: 330 Centimeter
• Guidewire Diameter: 0.009 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729996231 [Primary]
GS1	08714729996248 [Package]; Contains: 08714729996231; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900056

FDA Product Code

• MCX: CATHETER, CORONARY, ATHERECTOMY

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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [RotaWire™ Drive and wireClip™ Torquer]

• 08714729996262: Guidewire and Guidewire Manipulation Device
• 08714729996248: Guidewire and Guidewire Manipulation Device