AccessGUDID - DEVICE: ITN Implant (B487EXITN9245750)

GUDID

Device Identifier (DI) Information

Brand Name: ITN Implant
Version or Model: EXITN924575
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EXITN924575
Company Name: Exsomed Corporation

Primary DI Number: B487EXITN9245750
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 116722111 *Terms of Use

Device Description: ITN Implant is a stainless steel bone screw

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?
66497	Stress-therapy vibroacoustic headband	An electrically-powered wearable device intended to apply vibroacoustic therapy (VAT) stimuli to the head to treat stress and sleep disorder symptoms (e.g., insomnia, migraine, anxiety) by inducing a state of brain relaxation. It is typically in the form of a headband to be positioned over the forehead and temporal areas of the head, and includes dedicated software for vibration frequency programming from a wirelessly connected smart device (not included). It is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

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
Length: 75 Millimeter
Outer Diameter: 4.5 Millimeter

Device Record Status

Public Device Record Key: 48913731-21f8-4d85-a28f-1a5e14f525dc
Public Version Date: February 01, 2024
Public Version Number: 4
DI Record Publish Date: April 06, 2018