SOLOPATH STFI-2135
GUDID 50852381004314
SOLOPATH Balloon Expandable TransFemoral System
ONSET MEDICAL CORPORATION
Vascular catheter introduction set, nonimplantable| Primary Device ID | 50852381004314 |
| NIH Device Record Key | 3fa16eaf-8ca6-44bd-80ce-e76df92a4cc8 |
| Commercial Distribution Discontinuation | 2019-10-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SOLOPATH |
| Version Model Number | STFI-2135 |
| Catalog Number | STFI-2135 |
| Company DUNS | 144431850 |
| Company Name | ONSET 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
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| 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 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 35 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852381004319 [Primary] |
| GS1 | 50852381004314 [Package] Contains: 00852381004319 Package: Carton [39 Units] Discontinued: 2019-10-30 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 | 4 |
| Public Version Date | 2019-12-13 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [SOLOPATH]
| 50852381011909 | SOLOPATH Re-collapsible Balloon Access System |
| 50852381011893 | SOLOPATH Re-collapsible Balloon Access System |
| 50852381004413 | SOLOPATH Re-collapsible Access System |
| 50852381004406 | SOLOPATH Re-collapsible Access System |
| 50852381004390 | SOLOPATH Re-collapsible Access System |
| 50852381004383 | SOLOPATH Re-collapsible Access System |
| 50852381004352 | SOLOPATH Re-collapsible Access System |
| 50852381004345 | SOLOPATH Re-collapsible Access System |
| 50852381004314 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004307 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004277 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004260 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004253 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004246 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004239 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004222 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004215 | SOLOPATH Balloon Expandable TransFemoral System |
| 50852381004208 | 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 |
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