Nova Z

GUDID 00863593000280

Fiducial marker loaded needle assembly

C4 IMAGING, LLC

Radiological image marker, implantable

• Primary Device ID: 00863593000280
• NIH Device Record Key: 21684a6d-bf5d-4009-b1c3-19e067624cb6
• Commercial Distribution Discontinuation: 2025-10-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Nova Z
• Version Model Number: F-02-04-0111
• Company DUNS: 036470387
• Company Name: C4 IMAGING, LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863593000280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192771

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

[00863593000280]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-16
• Device Publish Date: 2025-10-06

On-Brand Devices [Nova Z]

• 00863593000297: Carton Containing up to 10 Fiducial Marker Loaded Needle Assemblies
• 00863593000280: Fiducial marker loaded needle assembly
• 00863593000266: Fiducial Marker