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| 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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