Micro18 MicroCross Catheter, CE

GUDID 00858480007121

ROXWOOD MEDICAL, INC.

Vascular microcatheter

• Primary Device ID: 00858480007121
• NIH Device Record Key: 0b3bead9-aa40-43d1-89a7-fb15cdb58b89
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Micro18 MicroCross Catheter, CE
• Version Model Number: RCX-0018
• 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	00858480007121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151082

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: 6
• Public Version Date: 2020-03-31
• Device Publish Date: 2018-04-19

On-Brand Devices [Micro18 MicroCross Catheter, CE]

• 00858480007121: RCX-0018
• B094RCX00180: RCX-0018