ImarC™ 040303

GUDID 10858015005476

Tissue Marker System - Core Delivery

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: 10858015005476
• NIH Device Record Key: 47a02e4f-0eec-4f83-948f-ed02ae5c15a0
• Commercial Distribution Discontinuation: 2017-12-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ImarC™
• Version Model Number: 040303
• Catalog Number: 040303
• Company DUNS: 883094039
• Company Name: Carbon Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858015005479 [Primary]
GS1	10858015005476 [Package]; Contains: 00858015005479; Package: Carton [10 Units]; Discontinued: 2017-12-07; Not in Commercial Distribution

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [ImarC™]

• 10858015005490: Tissue Marker System - Stereotactic Delivery
• 10858015005483: Tissue Marker System - Core Delivery
• 10858015005476: Tissue Marker System - Core Delivery
• 10858015005469: Tissue Marker System - Core Delivery
• 10858015005452: Tissue Marker System - Stereotactic Delivery