BIOMARC ® EX 040165
GUDID 10850002461302
FIDUCIAL MARKER SYSTEM
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 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 | 10850002461302 |
| NIH Device Record Key | 9dc853d5-184c-4c70-b36e-ce86af33e139 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOMARC ® EX |
| Version Model Number | 040165 |
| Catalog Number | 040165 |
| 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 | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM | |
| Phone | 6516538512 |
| INFO@CARBONMED.COM |
Device Dimensions
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 20 Gauge |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002461305 [Primary] |
| GS1 | 10850002461302 [Package] Contains: 00850002461305 Package: CARTON [3 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 | 2022-02-15 |
| Device Publish Date | 2022-02-07 |
Devices Manufactured by Carbon Medical Technologies, Inc.
| 10850002461302 - BIOMARC ® EX | 2022-02-15FIDUCIAL MARKER SYSTEM |
| 10850002461302 - BIOMARC ® EX | 2022-02-15 FIDUCIAL MARKER SYSTEM |
| 00850002461091 - BiomarC® Restore | 2021-12-24 LOW DENSITY FIDUCIAL MARKER |
| 00850002461107 - BIOMARC® RESTORE | 2021-12-24 LOW DENSITY FIDUCIAL MARKER |
| 00850002461152 - BIOMARC ® RESTORE | 2021-12-24 MIDDLE DENSITY FIDUCIAL MARKER |
| 00850002461169 - BIOMARC ® RESTORE | 2021-12-24 HIGH DENSITY FIDUCIAL MARKER |
| 00850002461176 - BIOMARC ® RESTORE | 2021-12-24 MIDDLE DENSITY FIDUCIAL MARKER |
| 00850002461183 - BIOMARC ® RESTORE | 2021-12-24 HIGH DENSITY FIDUCIAL MARKER |
| 10850002461067 - Carbon Bright ® | 2020-02-26 Fiducial Marker |
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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