BiomarC ® 040133

GUDID 10858015005070

Fiducial Marker, Gold

Carbon Medical Technologies, Inc.

Imaging lesion localization marker, implantable

• Primary Device ID: 10858015005070
• NIH Device Record Key: 90b82f6a-2a5d-42dc-9ec3-21c5f5774191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiomarC ®
• Version Model Number: 040133
• Catalog Number: 040133
• 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

• Outer Diameter: 0.9 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 0.9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858015005073 [Primary]
GS1	10858015005070 [Package]; Contains: 00858015005073; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130678

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-18

On-Brand Devices [BiomarC ®]

• 00858015005646: Coaxial Needle
• 10858015005087: Fiducial Marker - EX
• 10858015005070: Fiducial Marker, Gold
• 10858015005063: Tissue Marker, kV