SoundBite® Active Wire 14P
GUDID 17540265101024
The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console.
Soundbite Medical Solutions Inc
Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual| Primary Device ID | 17540265101024 |
| NIH Device Record Key | 7a1f5ce5-f7a7-4a1e-8e2f-46d6b675a19e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SoundBite® Active Wire 14P |
| Version Model Number | 900-0001885 |
| Company DUNS | 208993667 |
| Company Name | Soundbite Medical Solutions Inc |
| 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
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 300 Centimeter |
| Guidewire Diameter | 0.014 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17540265101024 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210839
FDA Product Code
| PDU | Catheter For Crossing Total Occlusions |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2021-06-30 |
On-Brand Devices [SoundBite® Active Wire 14P]
| 10754026501023 | The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral ( |
| 17540265101024 | The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral ( |
Trademark Results [SoundBite]
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