CenterCross Catheter,CE

GUDID 00858480007077

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter

• Primary Device ID: 00858480007077
• NIH Device Record Key: 55fa0ba9-d054-40a8-9580-186171d43bc5
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CenterCross Catheter,CE
• Version Model Number: CCX-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	00858480007077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140910

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

Devices Manufactured by ROXWOOD MEDICAL, INC.

• 00858480007008 - CenterCross Catheter: 2020-03-31
• 00858480007015 - Micro14 MicroCross Catheter: 2020-03-31
• 00858480007022 - Micro18 MicroCross Catheter: 2020-03-31
• 00858480007039 - Micro14es MicroCross Catheter: 2020-03-31
• 00858480007046 - MultiCross Catheter: 2020-03-31
• 00858480007053 - CenterCross Ultra Catheter: 2020-03-31
• 00858480007060 - CenterCross Ultra LV Catheter: 2020-03-31
• 00858480007077 - CenterCross Catheter,CE: 2020-03-31
• 00858480007077 - CenterCross Catheter,CE: 2020-03-31