AccessGUDID - DEVICE: FLASH MINI Ostial System (M917OCB4008BA0)

GUDID

Device Identifier (DI) Information

Brand Name: FLASH MINI Ostial System
Version or Model: OCB4008BA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OCB4008BA
Company Name: Verge Medical, Inc.

Primary DI Number: M917OCB4008BA0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078708447 *Terms of Use

Device Description: FLASH MINI Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 8mm

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 [?]
K131450	000
K152485	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 dry location at room temperature (~23°C)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Catheter Length: 135cm
Device Size Text, specify: Distal Balloon Length: 8mm
Device Size Text, specify: Distal Balloon Diameter: 4.0mm

Device Record Status

Public Device Record Key: 27954038-f9b5-4ce2-b4e0-24aba14a53aa
Public Version Date: May 01, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016