AccessGUDID - DEVICE: Cronus™ HP - OTW PTA BALLOON CATHETER (00383790004244)

GUDID

Device Identifier (DI) Information

Brand Name: Cronus™ HP - OTW PTA BALLOON CATHETER
Version or Model: NCH+84045
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIPRO MEDICAL CORPORATION

Primary DI Number: 00383790004244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 797372554 *Terms of Use

Device Description: OTW High Pressure Peripheral Balloon Catheter

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":	Yes
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 [?]
K151141	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
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: balloon diameter: 8mm
Device Size Text, specify: balloon length: 40mm
Device Size Text, specify: catheter length: 45cm

Device Record Status

Public Device Record Key: d7eb3a6a-3e0c-40c1-b03c-701fd07a5145
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016