AccessGUDID - DEVICE: NeuroBalloon™ (10381780035343)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroBalloon™
Version or Model: 7CBD10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7CBD10
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780035343
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use

Device Description: NeuroBalloon™ NEUROBALLOON™ 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:	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?
47157	Neural-tissue balloon catheter	A sterile, flexible tube with a balloon at the distal tip used for the compression or dilation of neural tissue under direct endoscopic or fluoroscopic vision. It is inserted percutaneously over a metal stylet and typically has a small (mini) diameter with an elongated or a double (figure of 8) balloon; it is made of plastic/silicone materials and may be supplied with the stylet. It is typically used to treat trigeminal neuralgia (controlled balloon compression of the trigeminal ganglion causes selected injury to the insulation on nerve fibres which relieves pain). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Do Not Use if Package is Damaged

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Balloon waist diameter upon inflation: 3.5 mm minimum at 0.6 ml (0.6cc) of air, 6 mm maximum at 1 ml (1cc) of air; Cath. 60cm mini. Length; for insertion into a F4 minimum (1.35mm) diameter channel

Device Record Status

Public Device Record Key: fd885f88-fbf8-4113-a64d-7a19f2316633
Public Version Date: May 15, 2023
Public Version Number: 6
DI Record Publish Date: August 08, 2016