Model: Serena Sure
DI: 00860005753093
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Serena Sure sleep apnea appliance
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2aef6f65-8d13-40e8-98a0-23830eb020b7
Distribution Status:
In Commercial Distribution
DUNS Number:
121617550
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860005753093
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47526
Name: Mandible-repositioning sleep-disordered breathing orthosis
Definition:
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.
FDA Product Codes
LRK
Device, Anti-Snoring