BIOMARC ® EX 040165
GUDID 10850002461302
FIDUCIAL MARKER SYSTEM
Carbon Medical Technologies, Inc.
Imaging lesion localization 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.
| 10850002461340 - BiomarC® | 2024-07-31 FIDUCIAL MARKER SYSTEM, EX |
| 10850002461357 - Carbon Bright ® | 2024-07-31 CARBON FIDUCIAL MARKER - DISTAL DELIVERY |
| 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 |
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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