| Primary Device ID | 00840303711827 |
| NIH Device Record Key | 124e30ba-631f-44ef-94d1-6512f8ed552c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEGA Ballast Distal Access Platform |
| Version Model Number | MEGABT09980 |
| Catalog Number | N/A |
| Company DUNS | 945543689 |
| Company Name | BALT USA LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.12 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature and away from light |