NES Reprocessed .035 Stryker Catheter R-S88901

GUDID B227RS889011

NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)

NORTH EAST SCIENTIFIC INC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: B227RS889011
• NIH Device Record Key: 7e9cdfe4-4e49-4d99-bcf9-990029234942
• Commercial Distribution Discontinuation: 2030-11-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed .035 Stryker Catheter
• Version Model Number: R-S88901
• Catalog Number: R-S88901
• 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: 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

Device Dimensions

• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Catheter Working Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B227RS889011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181126

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: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [NES Reprocessed .035 Stryker Catheter]

• B227RS889011: NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)
• 00850044399239: NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)