| Primary Device ID | 00842362100031 |
| NIH Device Record Key | ddf90d6b-0958-4c83-a0cb-e326606e5c94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DABRA 101 Catheter |
| Version Model Number | 101 |
| Company DUNS | 131845013 |
| Company Name | RA MEDICAL SYSTEMS, 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 | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842362100031 [Primary] |
| PDU | Catheter For Crossing Total Occlusions |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00842362100031]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-13 |
| 00842362100017 - Pharos | 2019-02-07 A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input |
| 00842362100024 - DABRA Laser System | 2018-07-06 A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input |
| 00842362100031 - DABRA 101 Catheter | 2018-07-06Percutaneous Catheter |
| 00842362100031 - DABRA 101 Catheter | 2018-07-06 Percutaneous Catheter |