Revolution Peripheral Atherectomy System 2006200133

GUDID 00857141005384

Revolution, 6F, 1.33mm, 200cm

Rex Medical, Inc.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00857141005384
• NIH Device Record Key: ec7fcf09-ac22-4733-80f3-165f97afa815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution Peripheral Atherectomy System
• Version Model Number: 2006200133
• Catalog Number: 2006200133
• Company DUNS: 110354748
• Company Name: Rex Medical, Inc.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 610-940-0665
• Email: sales@rexmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857141005384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212351

FDA Product Code

• MCW: Catheter, Peripheral, 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: 2025-12-24
• Device Publish Date: 2025-12-16

On-Brand Devices [Revolution Peripheral Atherectomy System]

• 00857141005414: Revolution, 4F, 1.33mm, 60cm
• 00857141005407: Revolution, 6F, 2.00mm, 200cm
• 00857141005391: Revolution, 6F, 1.66mm, 200cm
• 00857141005384: Revolution, 6F, 1.33mm, 200cm
• 00857141005377: Revolution, 7F, 2.33mm, 145cm
• 00857141005346: Revolution, 6F, 2.00mm, 145cm
• 00857141005339: Revolution, 6F, 1.66mm, 145cm
• 00857141005322: Revolution, 6F, 1.33mm, 145cm