| Primary Device ID | 07540299000488 |
| NIH Device Record Key | 35b3dc03-a30b-4d7a-b0a4-6fe54abecfe9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerWire 14 Radiofrequency Guidewire Kit |
| Version Model Number | PW14-300-20A |
| Company DUNS | 240389677 |
| Company Name | Baylis Medical Technologies 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 | true |
| 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 |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com | |
| Phone | 905-948-5800 |
| info@baylismedtech.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540299000488 [Primary] |
| PDU | Catheter For Crossing Total Occlusions |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-12 |
| Device Publish Date | 2025-12-04 |
| 07540299000488 | PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable |
| 07540299000471 | PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable |
| 07540299000433 | PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable |
| 07540299000426 | PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable |