BiomarC ® 040133
GUDID 10858015005070
Fiducial Marker, Gold
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 | 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 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| 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 |
Trademark Results [BiomarC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOMARC 78515741 not registered Dead/Abandoned |
Image Process Technology, Inc 2004-11-12 |
 BIOMARC 76434065 2985769 Live/Registered |
Carbon Medical Technologies, Inc. 2002-07-25 |
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