SML

Basic Information

• Brand Name: SML
• Primary DI: D85463603LS1
• Version / Model: 63603LS
• Company Name: SELANE PRODUCTS, INC.
• Labeler DUNS: 066642729
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-04
• Public Version: 4
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: f5c98dd0-8f84-4ddc-849c-2bce6c0f5fde

Device Description

FULL BREATH LOWER-THERMAL ACY W/ PTR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62239	Tongue-training sleep-disordered breathing orthosis	A removable, custom-made, intraoral device intended to improve tongue function/positioning through retraining of the tongue, by prohibiting certain tongue positions, primarily to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea). It is intended to fit onto the upper dental arcade and is made from polymer and metal materials manufactured to meet the specifications of an individual patient. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D85463603LS1	HIBCC