Cronus™ HP - OTW PTA BALLOON CATHETER

GUDID 00383790003971

OTW High Pressure Peripheral Balloon Catheter

NIPRO MEDICAL CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00383790003971
• NIH Device Record Key: 9a8cfae0-1d3a-4f00-920e-36511d8035e1
• Commercial Distribution Discontinuation: 2020-01-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cronus™ HP - OTW PTA BALLOON CATHETER
• Version Model Number: NCH+73045
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790003971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151141

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-30
• Device Publish Date: 2016-09-16

On-Brand Devices [Cronus™ HP - OTW PTA BALLOON CATHETER]

• 00383790004350: OTW High Pressure Peripheral Balloon Catheter
• 00383790004343: OTW High Pressure Peripheral Balloon Catheter
• 00383790004336: OTW High Pressure Peripheral Balloon Catheter
• 00383790004329: OTW High Pressure Peripheral Balloon Catheter
• 00383790004312: OTW High Pressure Peripheral Balloon Catheter
• 00383790004305: OTW High Pressure Peripheral Balloon Catheter
• 00383790004299: OTW High Pressure Peripheral Balloon Catheter
• 00383790004282: OTW High Pressure Peripheral Balloon Catheter
• 00383790004275: OTW High Pressure Peripheral Balloon Catheter
• 00383790004268: OTW High Pressure Peripheral Balloon Catheter
• 00383790004251: OTW High Pressure Peripheral Balloon Catheter
• 00383790004244: OTW High Pressure Peripheral Balloon Catheter
• 00383790004237: OTW High Pressure Peripheral Balloon Catheter
• 00383790004220: OTW High Pressure Peripheral Balloon Catheter
• 00383790004213: OTW High Pressure Peripheral Balloon Catheter
• 00383790004206: OTW High Pressure Peripheral Balloon Catheter
• 00383790004190: OTW High Pressure Peripheral Balloon Catheter
• 00383790004183: OTW High Pressure Peripheral Balloon Catheter
• 00383790004008: OTW High Pressure Peripheral Balloon Catheter
• 00383790003995: OTW High Pressure Peripheral Balloon Catheter
• 00383790003988: OTW High Pressure Peripheral Balloon Catheter
• 00383790003971: OTW High Pressure Peripheral Balloon Catheter
• 00383790003964: OTW High Pressure Peripheral Balloon Catheter
• 00383790003957: OTW High Pressure Peripheral Balloon Catheter
• 00383790003803: OTW High Pressure Peripheral Balloon Catheter
• 00383790003797: OTW High Pressure Peripheral Balloon Catheter
• 00383790003780: OTW High Pressure Peripheral Balloon Catheter
• 00383790003773: OTW High Pressure Peripheral Balloon Catheter
• 00383790003766: OTW High Pressure Peripheral Balloon Catheter
• 00383790003759: OTW High Pressure Peripheral Balloon Catheter
• 00383790003742: OTW High Pressure Peripheral Balloon Catheter
• 00383790003735: OTW High Pressure Peripheral Balloon Catheter
• 00383790003728: OTW High Pressure Peripheral Balloon Catheter
• 00383790003711: OTW High Pressure Peripheral Balloon Catheter
• 00383790003704: OTW High Pressure Peripheral Balloon Catheter
• 00383790003698: OTW High Pressure Peripheral Balloon Catheter
• 00383790003681: OTW High Pressure Peripheral Balloon Catheter
• 00383790003674: OTW High Pressure Peripheral Balloon Catheter
• 00383790003605: OTW High Pressure Peripheral Balloon Catheter
• 00383790003599: OTW High Pressure Peripheral Balloon Catheter
• 00383790003582: OTW High Pressure Peripheral Balloon Catheter
• 00383790003575: OTW High Pressure Peripheral Balloon Catheter
• 00383790003568: OTW High Pressure Peripheral Balloon Catheter
• 00383790003551: OTW High Pressure Peripheral Balloon Catheter
• 00383790003544: OTW High Pressure Peripheral Balloon Catheter
• 00383790003537: OTW High Pressure Peripheral Balloon Catheter
• 00383790003520: OTW High Pressure Peripheral Balloon Catheter
• 00383790003513: OTW High Pressure Peripheral Balloon Catheter
• 00383790003506: OTW High Pressure Peripheral Balloon Catheter
• 00383790003407: OTW High Pressure Peripheral Balloon Catheter