| Primary Device ID | 00818053023002 |
| NIH Device Record Key | 8818351c-bb52-46aa-b30e-2657e21be2fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ECLIPSE 2L |
| Version Model Number | ECL2L6x20 |
| 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 |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com | |
| Phone | 1-949-788-1443 |
| customerservice@balt-usa.com |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| Length | 160 Centimeter |
| Catheter Inner Diameter | 0.016 Inch |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818053023002 [Primary] |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-23 |
| Device Publish Date | 2019-07-15 |
| 00818053023002 | ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T |
| 00818053022982 | ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T |
| 00818053022968 | ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T |
| 00818053022944 | ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T |
| 00818053022937 | ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T |
| 00818053022920 | ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. T |