RotaWire™ and wireClip™ Torquer H802232390010

GUDID 08714729195573

Guidewire and Guidewire Manipulation Device

BOSTON SCIENTIFIC CORPORATION

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 08714729195573
• NIH Device Record Key: 0d0f71b3-f734-4da4-8994-2d2b158ad5b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RotaWire™ and wireClip™ Torquer
• Version Model Number: H802232390010
• Catalog Number: H802232390010
• 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: true
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729144168 [Primary]
GS1	08714729195573 [Package]; Contains: 08714729144168; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-03-31
• Device Publish Date: 2014-09-24

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

• 08714729195566: Guidewire and Guidewire Manipulation Device
• 08714729195573: Guidewire and Guidewire Manipulation Device