AccessGUDID - DEVICE: KLARITY MEDICAL (00817355023680)

GUDID

Device Identifier (DI) Information

Brand Name: KLARITY MEDICAL
Version or Model: RNB-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Klarity Medical Products, LLC

Primary DI Number: 00817355023680
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 034824691 *Terms of Use

Device Description: Klarity BiteLok™: complete package with BiteLok™, dental putty, QuickFit™ tool, and tongue placement devices

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
40898	Head/neck procedure positioner	A noninvasive device consisting of fixed or adjustable elements (e.g., helmet, frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine typically during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin
IYE	Accelerator, Linear, Medical

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: No
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: f4cdcac2-77ce-495d-9a27-5d0da30af5e0
Public Version Date: March 18, 2025
Public Version Number: 4
DI Record Publish Date: June 29, 2018