Cronus HP - High Pressure Peripheral Balloon Catheter

GUDID 00383790009119

OTW High Pressure Peripheral Balloon Catheter

NIPRO MEDICAL CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00383790009119
• NIH Device Record Key: b8bf20bf-31c1-4e03-bf9c-09cb9849d69f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cronus HP - High Pressure Peripheral Balloon Catheter
• Version Model Number: NHP+42080
• Company DUNS: 797372554
• Company Name: NIPRO MEDICAL CORPORATION
• 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: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com
• Phone: +1 (908) 393-7030
• Email: info@nipromed.com

Device Dimensions

• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 20 Millimeter
• Catheter Length: 80 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790009119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190037

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2022-05-02
• Device Publish Date: 2022-04-22

On-Brand Devices [Cronus HP - High Pressure Peripheral Balloon Catheter]

• 00383790009867: OTW High Pressure Peripheral Balloon Catheter
• 00383790009843: OTW High Pressure Peripheral Balloon Catheter
• 00383790009829: OTW High Pressure Peripheral Balloon Catheter
• 00383790009805: OTW High Pressure Peripheral Balloon Catheter
• 00383790009782: OTW High Pressure Peripheral Balloon Catheter
• 00383790009768: OTW High Pressure Peripheral Balloon Catheter
• 00383790009744: OTW High Pressure Peripheral Balloon Catheter
• 00383790009720: OTW High Pressure Peripheral Balloon Catheter
• 00383790009539: OTW High Pressure Peripheral Balloon Catheter
• 00383790009515: OTW High Pressure Peripheral Balloon Catheter
• 00383790009430: OTW High Pressure Peripheral Balloon Catheter
• 00383790009416: OTW High Pressure Peripheral Balloon Catheter
• 00383790009331: OTW High Pressure Peripheral Balloon Catheter
• 00383790009317: OTW High Pressure Peripheral Balloon Catheter
• 00383790009294: OTW High Pressure Peripheral Balloon Catheter
• 00383790009270: OTW High Pressure Peripheral Balloon Catheter
• 00383790009256: OTW High Pressure Peripheral Balloon Catheter
• 00383790009232: OTW High Pressure Peripheral Balloon Catheter
• 00383790009218: OTW High Pressure Peripheral Balloon Catheter
• 00383790009195: OTW High Pressure Peripheral Balloon Catheter
• 00383790009171: OTW High Pressure Peripheral Balloon Catheter
• 00383790009157: OTW High Pressure Peripheral Balloon Catheter
• 00383790009133: OTW High Pressure Peripheral Balloon Catheter
• 00383790009119: OTW High Pressure Peripheral Balloon Catheter