| Primary Device ID | 20841156111448 |
| NIH Device Record Key | fdb70efd-8fec-4a77-b714-81667f9b3347 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R350 |
| Version Model Number | IPN930522 |
| Catalog Number | 7390 |
| Company DUNS | 002348191 |
| Company Name | TELEFLEX INCORPORATED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841156111441 [Primary] |
| GS1 | 20841156111448 [Package] Contains: 10841156111441 Package: Box [5 Units] In Commercial Distribution |
| DQX | Wire, guide, catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-12 |
| Device Publish Date | 2025-06-04 |
| 50841156101174 | R350 V2 Guidewire |
| 20841156111448 | R350 Guidewire |