Nova 5

GUDID 00863593000242

The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.

C4 IMAGING, LLC

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 00863593000242
• NIH Device Record Key: a90e2332-07a8-423e-8a6e-499e13db6351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nova 5
• Version Model Number: F-01-03-0011
• Company DUNS: 003065466
• 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: false
• 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	00863593000242 [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: false

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

[00863593000242]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Nova 5]

• 00863593000259: The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containin
• 00863593000242: The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containin