RX NC TAKERU DC-RZ4515UA2

GUDID 04540778170612

RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX NC TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).

KANEKA CORPORATION

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 04540778170612
• NIH Device Record Key: 172dc09a-1f1c-459f-9421-9111ff3ec8a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RX NC TAKERU
• Version Model Number: DC-RZ4515UA2
• Catalog Number: DC-RZ4515UA2
• Company DUNS: 690535406
• Company Name: KANEKA 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: true
• 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: 800-888-3786
• Email: tmccustomer.admin@terumomedical.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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540778170612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170941

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-09-20

On-Brand Devices [RX NC TAKERU]

• 04540778170995: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170971: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170957: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170933: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170919: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170896: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170872: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170858: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170834: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170810: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170797: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170773: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170759: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170735: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170711: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170698: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170674: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170650: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170636: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170612: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170599: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170575: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170551: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170537: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170513: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170490: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170476: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170452: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170438: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170414: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170391: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170377: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170353: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170339: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170315: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170292: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170278: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170254: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170230: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170216: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170193: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170179: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170155: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170131: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170117: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170094: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170070: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170056: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170032: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe
• 04540778170018: RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Cathe