Rotaglide™ H7493948300170

GUDID 00191506005566

Lubricant

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 00191506005566
• NIH Device Record Key: b71807b0-637f-4203-bcfd-2e73c5dbf039
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotaglide™
• Version Model Number: H7493948300170
• Catalog Number: H7493948300170
• 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	00191506005559 [Primary]
GS1	00191506005566 [Package]; Contains: 00191506005559; Package: [10 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: 2023-11-13
• Device Publish Date: 2023-11-03

On-Brand Devices [Rotaglide™]

• 08714729847557: Lubricant
• 08714729837619: Lubricant
• 00191506005580: Lubricant
• 00191506005566: Lubricant