NES Reprocessed Eagle Eye Platinum Long Tip Stryker R-S85900P

GUDID B227RS85900P1

NES Reprocessed Eagle Eye Platinum Long Tip Catheter manufactured for Stryker (SSS)

NORTH EAST SCIENTIFIC INC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: B227RS85900P1
• NIH Device Record Key: 7dafdab2-80f5-4e0f-9611-aef04ad08c75
• Commercial Distribution Discontinuation: 2030-11-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed Eagle Eye Platinum Long Tip Stryker
• Version Model Number: R-S85900P
• Catalog Number: R-S85900P
• Company DUNS: 608625823
• Company Name: NORTH EAST SCIENTIFIC 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

• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com
• Phone: 203-756-2111
• Email: info@smarthealth-care.com

Device Dimensions

• 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
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B227RS85900P1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223026

FDA Product Code

• OWQ: Reprocessed Intravascular Ultrasound Catheter

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: 2024-08-23
• Device Publish Date: 2024-08-15

Devices Manufactured by NORTH EAST SCIENTIFIC INC

• 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: 2024-08-23NES Reprocessed Eagle Eye Platinum Long Tip 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