BiomarC® 040121
GUDID 00858015005547
Fiducial Marker System, kV
Carbon Medical Technologies, Inc.
Imaging lesion localization marker, implantable| Primary Device ID | 00858015005547 |
| NIH Device Record Key | b85f353f-b17b-4881-81ce-08f35cf67cdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiomarC® |
| Version Model Number | 040121 |
| Catalog Number | 040121 |
| 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
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Length | 3 Millimeter |
| Outer Diameter | 1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858015005547 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110772
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 | 2015-11-30 |
On-Brand Devices [BiomarC®]
| 10858015005667 | Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery |
| 10858015005650 | Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery |
| 10858015005599 | Preloaded Tribell Carbon Tissue Marker - Sideport Delivery |
| 10858015005582 | Preloaded Carbon Tissue Marker, Needle Tip Delivery |
| 10858015005575 | Fiducial Marker System with Enhanced Visibility, kV |
| 10858015005568 | Fiducial Marker System with Enhanced Visibility, kV |
| 10858015005551 | Fiducial Marker System with Enhanced Visibility, kV |
| 00858015005547 | Fiducial Marker System, kV |
| 10858015005537 | Fiducial Marker System with Enhanced Visibility, kV |
| 10858015005520 | Fiducial Marker System, kV |
| 10858015005513 | Fiducial Marker, kV |
| 10858015005506 | Fiducial Marker, Secure |
| 10858015005292 | Preloaded Carbon Tissue Marker with Enhanced MRI Visibility - Distal Needle Tip Delivery |
| 10858015005285 | Preloaded Barbell Carbon Tissue Marker - Distal Needle Tip Delivery |
| 10858015005278 | Preloaded Barbell Carbon Tissue Marker - Distal Needle Tip Delivery |
| 10858015005261 | Preloaded Carbon Tissue Marker - Distal Delivery |
| 10858015005254 | Preloaded Carbon Tissue Marker with Enhanced MRI Visibility - Sideport Delivery |
| 10858015005247 | Preloaded Barbell Carbon Tissue Marker - Sideport Delivery |
| 10858015005230 | Preloaded Barbell Carbon Tissue Marker, Sideport Delivery |
| 10858015005223 | Preloaded Barbell Carbon Tissue Marker - Distal Delivery |
| 10858015005216 | Preloaded Barbell Carbon Tissue Marker - Sideport Delivery |
| 10858015005209 | Carbon Tissue Marker System with Enhanced Visibility, kV |
| 10858015005193 | Fiducial Marker System, Gold |
| 10858015005186 | Carbon Tissue Marker System with Enhanced Visibility, kV |
| 10858015005179 | Carbon Tissue Marker System with Enhanced Visibility, kV |
| 00858015005165 | Carbon Tissue Marker System, kV |
| 10858015005155 | Fiducial Marker System, Gold |
| 10858015005148 | Carbon Tissue Marker System, kV |
| 10858015005131 | Fiducial Marker System, Gold |
| 10858015005124 | Carbon Tissue Marker System, kV |
| 10858015005117 | Preloaded Carbon Tissue Marker, Distal Delivery |
| 10858015005100 | Preloaded Carbon Tissue Marker, Needle Tip Delivery |
| 10858015005094 | Preloaded Carbon Tissue Marker, Needle Tip Delivery |
| 10858015005056 | Fiducial Marker System, EX |
| 00858015005042 | Fiducial Marker System, PRO |
| 00858015005035 | Marker System, PRO |
| 00858015005028 | Marker System, PRO |
| 10850002461340 | FIDUCIAL MARKER SYSTEM, EX |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.