| Primary Device ID | 00858015005950 |
| NIH Device Record Key | 10895820-c326-4ac9-909a-27ac7d79e7b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Injection Procedure Kit |
| Version Model Number | 101088 |
| Catalog Number | 101088 |
| Company DUNS | 883094039 |
| Company Name | Carbon Medical Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00858015005950 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2017-12-04 |
| 10850002461340 - BiomarC® | 2024-07-31 FIDUCIAL MARKER SYSTEM, EX |
| 10850002461357 - Carbon Bright ® | 2024-07-31 CARBON FIDUCIAL MARKER - DISTAL DELIVERY |
| 10850002461302 - BIOMARC ® EX | 2022-02-15 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 |