AccessGUDID - DEVICE: AngioSculpt®PTCA Scoring Balloon Catheter (00813132022112)

GUDID

Device Identifier (DI) Information

Brand Name: AngioSculpt®PTCA Scoring Balloon Catheter
Version or Model: 2001-2515
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2001-2515
Company Name: Spectranetics Corporation

Primary DI Number: 00813132022112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: AngioSculpt® PTCA Scoring 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":	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?
44088	Coronary angioplasty balloon catheter, cutting/scoring	A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical atherotomes) intended to remove stenotic material. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWX	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Keep Dry
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.5 Millimeter
Length: 15 Millimeter

Device Record Status

Public Device Record Key: 3b83f944-7b51-490c-a705-a3b722171064
Public Version Date: October 26, 2021
Public Version Number: 7
DI Record Publish Date: March 09, 2015