AccessGUDID - DEVICE: Flextome® Cutting Balloon® (08714729808701)

GUDID

Device Identifier (DI) Information

Brand Name: Flextome® Cutting Balloon®
Version or Model: H749CBO3275150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H749CBO3275150
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729808701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Microsurgical Dilatation Device

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 [?]
P950020	010
P950020	011
P950020	012
P950020	013
P950020	014
P950020	015
P950020	017
P950020	032
P950020	036
P950020	055

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 15 mm Length
Device Size Text, specify: 2.75 mm Diameter

Device Record Status

Public Device Record Key: d12dc9cf-543f-4674-a8cb-b273dde5e4fa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014