AccessGUDID - DEVICE: The Luco Hybrid OSA Appliance (00810002220241)

GUDID

Device Identifier (DI) Information

Brand Name: The Luco Hybrid OSA Appliance
Version or Model: 3014680794
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JOHN'S DENTAL LABORATORY INC

Primary DI Number: 00810002220241
Issuing Agency: GS1
Commercial Distribution End Date: November 07, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 016649253 *Terms of Use

Device Description: An intraoral device designed to treat primary snoring and mild to moderate obstructive sleep apnea, as well as sleep bruxism and aid in the treatment of associated tension/migraine type headaches in adults. This device is reusable.

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:	No
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?
47526	Mandible-repositioning sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRK	Device, Anti-Snoring
OCO	Mouthguard, Migraine/Tension Headache
MQC	Mouthguard, Prescription

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: da13e98e-a445-46e6-86dd-17b193263aae
Public Version Date: November 08, 2024
Public Version Number: 3
DI Record Publish Date: March 28, 2023