AccessGUDID - DEVICE: VenSure Light Balloon Dilation System (04260759931253)

GUDID

Device Identifier (DI) Information

Brand Name: VenSure Light Balloon Dilation System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E 01 3536
Company Name: Fiagon GmbH

Primary DI Number: 04260759931253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312623008 *Terms of Use

Device Description: Balloon Dilation system as set including Balloon dilation device, Inflation device with tubes, light-confirmation 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:	Yes
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?
48140	Nasal/paranasal balloon catheter	A sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	Instrument, Ent Manual Surgical
PNZ	Eustachian Tube Balloon Dilation Device

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d91f7bf7-b4be-432e-a734-53e58876294f
Public Version Date: January 08, 2024
Public Version Number: 5
DI Record Publish Date: October 14, 2022