Classic

GUDID 00851826007021

Oral Device For The Treatment Of Obstructive Sleep Apnea.

SOMNOMED, INC.

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00851826007021
NIH Device Record Key16d63107-dd1e-4bbe-a83a-934c896da03c
Commercial Distribution StatusIn Commercial Distribution
Brand NameClassic
Version Model NumberC1000
Company DUNS623527962
Company NameSOMNOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888447-6673
Emailcusotmerservice@somnomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851826007021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

Devices Manufactured by SOMNOMED, INC.

00851826007281 - SomnoDent AVANT2024-08-22 SomnoDent AVANT with Strap Kit A
00851826007298 - SomnoDent AVANT2024-08-22 SomnoDent AVANT with Strap Kit B
00851826007304 - SomnoDent AVANT2024-08-22 SomnoDent AVANT with Strap Kit C
00851826007311 - SomnoDent AVANT2024-08-22 SomnoDent AVANT Strap Kit A
00851826007328 - SomnoDent AVANT2024-08-22 SomnoDent AVANT Strap Kit B
00851826007335 - SomnoDent AVANT2024-08-22 SomnoDent AVANT Strap Kit C
00851826007342 - SomnoDent AVANT2024-08-22 SomnoDent AVANT Strap Kit D
00851826007199 - SomnoDent AVANT 2019-09-06 SomnoDent Avant kit with Large Strap Set

Trademark Results [Classic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLASSIC
CLASSIC
98655577 not registered Live/Pending
Custom Apple Packers, Inc.
2024-07-18
CLASSIC
CLASSIC
98592320 not registered Live/Pending
The Andwin Corporation
2024-06-09
CLASSIC
CLASSIC
98554522 not registered Live/Pending
Express Window Films LLC
2024-05-16
CLASSIC
CLASSIC
97585693 not registered Live/Pending
Level Trade, Inc.
2022-09-09
CLASSIC
CLASSIC
97521838 not registered Live/Pending
Travis Body and Trailer, Inc.
2022-07-27
CLASSIC
CLASSIC
97383604 not registered Live/Pending
Class Entertainment
2022-04-27
CLASSIC
CLASSIC
97374015 not registered Live/Pending
Medi-Dyne Healthcare Products, Ltd.
2022-04-21
CLASSIC
CLASSIC
97304909 not registered Live/Pending
Power Gripps, USA, Inc.
2022-03-10
CLASSIC
CLASSIC
90879701 not registered Live/Pending
Pillow Cube, Inc.
2021-08-12
CLASSIC
CLASSIC
90795554 not registered Live/Pending
L.B. Plastics Incorporated
2021-06-25
CLASSIC
CLASSIC
90579929 not registered Live/Pending
Fulton Group N.A., Inc.
2021-03-15
CLASSIC
CLASSIC
90555348 not registered Live/Pending
Swanson Group Inc.
2021-03-02

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