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 ID04540778170612
NIH Device Record Key172dc09a-1f1c-459f-9421-9111ff3ec8a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRX NC TAKERU
Version Model NumberDC-RZ4515UA2
Catalog NumberDC-RZ4515UA2
Company DUNS690535406
Company NameKANEKA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-888-3786
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Device Size Text, specify0
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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104540778170612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2017-09-20

On-Brand Devices [RX NC TAKERU]

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

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