| Primary Device ID | 00850044399154 |
| NIH Device Record Key | 40cf2c28-c803-4d20-9b69-47821860410d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
| Version Model Number | R-85900P |
| Company DUNS | 608625823 |
| Company Name | NORTH EAST SCIENTIFIC INC |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com | |
| Phone | 203-756-2111 |
| sales@nescientific.com |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Catheter Working Length | 150 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 5 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850044399154 [Primary] |
| HIBCC | B227ARJ5100 [Previous] |
| OWQ | Reprocessed Intravascular Ultrasound 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 | 2025-05-29 |
| Device Publish Date | 2025-05-21 |
| 00850044399000 - NES Reprocessed Varicose Vein RF Catheter | 2025-05-29 The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-60) is intended for endovascular coagulation of blood |
| 00850044399017 - NES Reprocessed Varicose Vein RF Catheter | 2025-05-29 The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended for endovascular coagulation of blood |
| 00850044399024 - NES Reprocessed Varicose Vein RF Catheter | 2025-05-29 The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-3-60) is intended for endovascular coagulation of blood |
| 00850044399031 - NES Reprocessed RF Stylet (RFS) | 2025-05-29 |
| 00850044399048 - EsoSure | 2025-05-29 The EsoSure Esophageal Retractor is intended to move the esophagus. |
| 00850044399055 - NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter | 2025-05-29 |
| 00850044399062 - NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter | 2025-05-29 The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NE |
| 00850044399079 - NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter | 2025-05-29 |