CenterCross Ultra Catheter, CE

GUDID 00858480007091

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter

• Primary Device ID: 00858480007091
• NIH Device Record Key: 752a1750-8ddf-450b-813d-2c73568f4b85
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CenterCross Ultra Catheter, CE
• Version Model Number: UCX-0100
• Company DUNS: 055819211
• Company Name: ROXWOOD 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858480007091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160681

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2020-03-31
• Device Publish Date: 2018-04-19

On-Brand Devices [CenterCross Ultra Catheter, CE]

• 00858480007091: UCX-0100
• B094UCX01000: UCX-0100