BiomarC ® 040143
GUDID 00858015005646
Coaxial Needle
Carbon Medical Technologies, Inc.
Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use| Primary Device ID | 00858015005646 |
| NIH Device Record Key | 2aa4331d-eb10-4e9a-b525-c4c449d487b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiomarC ® |
| Version Model Number | 040143 |
| Catalog Number | 040143 |
| Company DUNS | 883094039 |
| Company Name | Carbon Medical Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| 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 | |
| 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 | |
| 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 |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 8.5 Centimeter |
| Needle Gauge | 18 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858015005646 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133148
FDA Product Code
| NEU | Marker, Radiographic, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-10-12 |
On-Brand Devices [BiomarC ® ]
| 00858015005646 | Coaxial Needle |
| 10858015005087 | Fiducial Marker - EX |
| 10858015005070 | Fiducial Marker, Gold |
| 10858015005063 | Tissue Marker, kV |
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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