Carbon Bright ® 040154
GUDID 10850002461074
Fiducial Marker System
Carbon Medical Technologies, Inc.
Imaging lesion localization marker, implantable| Primary Device ID | 10850002461074 |
| NIH Device Record Key | 90522901-78f5-4fd3-9d73-625d8a74f122 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Carbon Bright ® |
| Version Model Number | 040154 |
| Catalog Number | 040154 |
| 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
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Outer Diameter | 0.7 Millimeter |
| Length | 5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002461077 [Primary] |
| GS1 | 10850002461074 [Package] Contains: 00850002461077 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 | 2020-02-26 |
| Device Publish Date | 2020-02-18 |
On-Brand Devices [Carbon Bright ®]
| 10850002461074 | Fiducial Marker System |
| 10850002461067 | Fiducial Marker |
| 10850002461357 | CARBON FIDUCIAL MARKER - DISTAL DELIVERY |
Trademark Results [Carbon Bright]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARBON BRIGHT 87814203 5579779 Live/Registered |
Fields, Perry L. 2018-02-28 |
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