Speed-Torque®
GUDID 10860003987367
Speed-Torque® BNS
Vascugenix, LLC
Vascular guide-catheter, single-use| Primary Device ID | 10860003987367 |
| NIH Device Record Key | 058893bd-87e8-487c-9bc7-77bafb1116bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Speed-Torque® |
| Version Model Number | VSXT002 |
| Company DUNS | 117166275 |
| Company Name | Vascugenix, LLC |
| Device Count | 1000 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com | |
| Phone | 5015008025 |
| Info@vascugenix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003987360 [Primary] |
| GS1 | 00860003987377 [Unit of Use] |
| GS1 | 10860003987367 [Package] Contains: 00860003987360 Package: Case [2 Units] In Commercial Distribution |
FDA Product Code
| PTL | Wire, Guide, Catheter, Exempt |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
[10860003987367]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-11 |
| Device Publish Date | 2022-11-03 |
On-Brand Devices [Speed-Torque®]
| 10860003987367 | Speed-Torque® BNS |
| 10860003987350 | Speed-Torque® Device Pouch |
Trademark Results [Speed-Torque]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEED-TORQUE 88675261 not registered Live/Pending |
Vascugenix, Inc 2019-10-31 |
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