| Primary Device ID | 00860006823238 |
| NIH Device Record Key | 6b52f404-6242-421d-aefc-34192ec08c7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Runnels Steerable Introducer™ (rSI) |
| Version Model Number | 001031 |
| Company DUNS | 080585251 |
| Company Name | Through The Cords, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com | |
| Phone | 8019173851 |
| info@ttcmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006823238 [Primary] |
| GS1 | 00860006823245 [Package] Package: Box [5 Units] In Commercial Distribution |
| GS1 | 00860006823252 [Package] Contains: 00860006823245 Package: Case [20 Units] In Commercial Distribution |
| BSR | Stylet, Tracheal Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
| 00850059297070 - Runnels Steerable Introducer™ #2.5 Oral/Nasal | 2024-10-31 Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 12 Fr, latex free, single use, sterile, fits |
| 00850059297018 - Runnels Steerable Introducer™ #5 Nasal | 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 91.5 CM, 15 Fr, latex free, single use, sterile, fit |
| 00850059297049 - Runnels Steerable Introducer™ #2 Oral/Nasal | 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 62 CM, 12 Fr, latex free, single use, sterile, fits |
| 00850059297100 - Runnels Steerable Introducer™ #3 Oral/Nasal | 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 15 Fr, latex free, single use, sterile, fits |
| 00850059297131 - Runnels Steerable Introducer™ DLT (35F/37F) | 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 12 Fr, latex free, single use, sterile, fit |
| 00850059297162 - Runnels Steerable Introducer™ DLT (39F/41F) | 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 15 Fr, latex free, single use, sterile, fit |
| 00850059297223 - Runnels Steerable Introducer™ #4 Oral | 2024-04-01 Pre-lubricated articulating introducer with intuitive colored depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits |
| 00850059297193 - Runnels Steerable Introducer™ #4 Nasal | 2024-02-05 Pre-lubricated articulating introducer with intuitive colored depth system, 77 CM, 15 Fr, latex free, single use, sterile, fits |