| Primary Device ID | B227NRP3683 |
| NIH Device Record Key | eb9e3f34-df6b-4180-9288-9215b15f053a |
| Commercial Distribution Discontinuation | 2030-11-24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter |
| Version Model Number | R-420-006 |
| Catalog Number | R-420-006 |
| Company DUNS | 608625823 |
| Company Name | NORTH EAST SCIENTIFIC INC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B227NRP3683 [Primary] |
| QTF | Reprocessed Atherectomy 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 | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
| B227RS889011 - NES Reprocessed .035 Stryker Catheter | 2024-08-26 NES Reprocessed .035 IVUS reprocessed for Stryker (SSS) |
| B227R85900PST1 - NES Reprocessed Eagle Eye Platinum Short Tip Stryker | 2024-08-23 NES Reprocessed Eagle Eye Platinum Short Tip Catheter reprocessed for Stryker (SSS) |
| B227RS014R1 - NES Reprocessed .014 Stryker Catheter | 2024-08-23 NES Reprocessed .014 IVUS Catheter manufactured for Stryker (SSS) |
| B227RS85900P1 - NES Reprocessed Eagle Eye Platinum Long Tip Stryker | 2024-08-23 NES Reprocessed Eagle Eye Platinum Long Tip Catheter manufactured for Stryker (SSS) |
| B227NRP1301 - NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
| B227NRP1302 - NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
| B227NRP1303 - NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
| B227NRP3681 - NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |