Model: A5133-97
Catalog: A5133-97
DI: 08033707104513
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
TELESCOPIC ADVANCER SB M2 DUAL 7mmMEDIUM
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fa205ffa-68a5-4318-9250-abd1350c2704
Distribution Status:
In Commercial Distribution
DUNS Number:
432167294
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08033707104513
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
DYJ
Retainer, Screw Expansion, Orthodontic