Carbon Bright® 040152
GUDID 10850002461050
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 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 | 10850002461050 |
| NIH Device Record Key | e9fed457-46a1-4597-b63d-baf5d06561d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Carbon Bright® |
| Version Model Number | 040152 |
| Catalog Number | 040152 |
| 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 |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 5 Millimeter |
| Outer Diameter | 1 Millimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002461053 [Primary] |
| GS1 | 10850002461050 [Package] Contains: 00850002461053 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 | 2020-01-16 |
| Device Publish Date | 2020-01-08 |
On-Brand Devices [Carbon Bright®]
| 10850002461050 | Fiducial Marker System |
| 10850002461043 | Fiducial Marker |
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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