SOLOPATH STFI-2135
GUDID 50389701012228
SOLOPATH Balloon Expandable TransFemoral System
TERUMO MEDICAL CORPORATION
Vascular catheter introduction set, nonimplantable| Primary Device ID | 50389701012228 |
| NIH Device Record Key | 7a3d7701-8b9d-430a-8817-685a002728c0 |
| Commercial Distribution Discontinuation | 2019-11-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SOLOPATH |
| Version Model Number | STFI-2135 |
| Catalog Number | STFI-2135 |
| Company DUNS | 131489882 |
| Company Name | TERUMO MEDICAL CORPORATION |
| 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 | 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389701012223 [Primary] |
| GS1 | 50389701012228 [Package] Contains: 00389701012223 Package: Carton [39 Units] Discontinued: 2019-11-15 Not in Commercial Distribution |
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-12 |
| Device Publish Date | 2018-05-17 |
On-Brand Devices [SOLOPATH]
| 50389701012303 | SOLOPATH Re-collapsible Access System |
| 50389701012297 | SOLOPATH Re-collapsible Access System |
| 50389701012280 | SOLOPATH Re-collapsible Access System |
| 50389701012273 | SOLOPATH Re-collapsible Access System |
| 50389701012266 | SOLOPATH Re-collapsible Balloon Access System |
| 50389701012259 | SOLOPATH Re-collapsible Balloon Access System |
| 50389701012242 | SOLOPATH Re-collapsible Access System |
| 50389701012235 | SOLOPATH Re-collapsible Access System |
| 50389701012228 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012211 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012204 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012198 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012181 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012174 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012167 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012150 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012143 | SOLOPATH Balloon Expandable TransFemoral System |
| 50389701012136 | SOLOPATH Balloon Expandable TransFemoral System |
Trademark Results [SOLOPATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLOPATH 77137053 3565247 Live/Registered |
Onset Medical Corporation 2007-03-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.