HARBOR 04-OCCLUDE-065

GUDID 00850072397573

HARBOR Occlusion Device

Nuvascular, Inc.

Non-neurovascular embolization plug, metallic

• Primary Device ID: 00850072397573
• NIH Device Record Key: 00755ad1-854f-4f56-a45e-1528d4d9d6d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARBOR
• Version Model Number: 04-OCCLUDE-065
• Catalog Number: 04-OCCLUDE-065
• Company DUNS: 119270166
• Company Name: Nuvascular, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com
• Phone: 1-855-688-2728
• Email: customerservice@nuvascular.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850072397573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250133

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2025-08-07
• Device Publish Date: 2025-07-30

On-Brand Devices [HARBOR]

• 00850072397634: HARBOR Occlusion Device
• 00850072397627: HARBOR Occlusion Device
• 00850072397610: HARBOR Occlusion Device
• 00850072397603: HARBOR Occlusion Device
• 00850072397597: HARBOR Occlusion Device
• 00850072397580: HARBOR Occlusion Device
• 00850072397573: HARBOR Occlusion Device
• 00850072397566: HARBOR Occlusion Device
• 00850072397559: HARBOR Occlusion Device
• 00850072397542: HARBOR Occlusion Device
• 00850072397535: HARBOR Occlusion Device
• 00850072397528: HARBOR Occlusion Device
• 00850072397511: HARBOR Occlusion Device
• 00850072397504: HARBOR Occlusion Device
• 00850072397498: HARBOR Occlusion Device
• 00850072397481: HARBOR Occlusion Device