Rotaglide™ H7492354800160

GUDID 08714729837619

Lubricant

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 08714729837619
• NIH Device Record Key: aac21594-6cd7-40d1-9556-9abe4f2a950e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotaglide™
• Version Model Number: H7492354800160
• Catalog Number: H7492354800160
• 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	08714729837619 [Package]; Contains: 08714729855507; Package: [6 Units]; In Commercial Distribution
GS1	08714729855507 [Primary]

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: 5
• Public Version Date: 2021-04-06
• Device Publish Date: 2015-01-21

On-Brand Devices [Rotaglide™]

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