AccessGUDID - DEVICE: CROSPERIO OTW (04540778164659)

GUDID

Device Identifier (DI) Information

Brand Name: CROSPERIO OTW
Version or Model: BD-B35200MW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BD-B35200MW
Company Name: KANEKA CORPORATION

Primary DI Number: 04540778164659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690535406 *Terms of Use

Device Description: CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW 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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Peripheral angioplasty balloon catheter, basic	A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Peripheral angioplasty balloon catheter, basic

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
LIT	Catheter, Angioplasty, Peripheral, Transluminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160013	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

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

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Maximum Guidewire Diameter; 0.014 inch
Device Size Text, specify: Compatible Sheath Diameter; 4 Fr
Device Size Text, specify: Rated Burst Pressure; 14 atm
Device Size Text, specify: Nominal Pressure; 8 atm
Device Size Text, specify: Shaft Diameter; 3.8 Fr
Device Size Text, specify: Catheter Working Length; 900 mm
Device Size Text, specify: Balloon Length; 200 mm
Device Size Text, specify: Balloon Diameter; 3.5 mm

Device Record Status

Public Device Record Key: eb849abc-8740-4cc2-b3c0-ab692d62899a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 26, 2016