AccessGUDID - DEVICE: OTW TAKERU (04540778169234)

GUDID

Device Identifier (DI) Information

Brand Name: OTW TAKERU
Version or Model: DC-PY2015UA2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DC-PY2015UA2
Company Name: KANEKA CORPORATION

Primary DI Number: 04540778169234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690535406 *Terms of Use

Device Description: OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47732	Coronary angioplasty balloon catheter, basic	A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172264	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Maximum Guidewire Diameter; 0.014 inch
Device Size Text, specify: Compatible Guiding Catheter; 5 Fr
Device Size Text, specify: Rated Burst Pressure; 14 atm
Device Size Text, specify: Nominal Pressure; 6 atm
Device Size Text, specify: Proximal Shaft Diameter; 3.3 Fr
Device Size Text, specify: Distal Shaft Diameter; 2.7 Fr
Device Size Text, specify: Catheter Working Length; 1450 mm
Device Size Text, specify: Balloon Length; 15 mm
Device Size Text, specify: Balloon Diameter; 2.0 mm

Device Record Status

Public Device Record Key: f02ea0bc-95e1-4be4-8839-12e7ad313288
Public Version Date: October 07, 2019
Public Version Number: 3
DI Record Publish Date: March 26, 2018