Carbon Bright ® 040153

GUDID 10850002461067

Fiducial Marker

Carbon Medical Technologies, Inc.

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: 10850002461067
• NIH Device Record Key: fb7799d8-283e-4c47-ac7e-de8f41067650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carbon Bright ®
• Version Model Number: 040153
• Catalog Number: 040153
• Company DUNS: 883094039
• Company Name: Carbon Medical Technologies, 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: 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

Customer Support Contacts

• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com
• Phone: 8882070262
• Email: info@carbonmed.com

Device Dimensions

• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002461060 [Primary]
GS1	10850002461067 [Package]; Contains: 00850002461060; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132064

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [Carbon Bright ®]

• 10850002461074: Fiducial Marker System
• 10850002461067: Fiducial Marker