Flex

GUDID 00851826007038

Oral Device For The Treatment Of Obstructive Sleep Apnea.

SOMNOMED, INC.

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00851826007038
NIH Device Record Keyf54f72bd-072b-4fac-a13f-1d6dec7bf34a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex
Version Model NumberF3000
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

Phone888-447-6673
Emailcustomerservice@somnomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851826007038 [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 [Flex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEX
FLEX
98802176 not registered Live/Pending
University of Tennessee Research Foundation
2024-10-15
FLEX
FLEX
98801972 not registered Live/Pending
University of Tennessee Research Foundation
2024-10-15
FLEX
FLEX
98776701 not registered Live/Pending
Flex-Tax, Inc.
2024-09-29
FLEX
FLEX
98705560 not registered Live/Pending
SITA B.V.
2024-08-19
FLEX
FLEX
98527277 not registered Live/Pending
Financial Industry Regulatory Authority, Inc.
2024-04-30
FLEX
FLEX
98516812 not registered Live/Pending
GRADIENT MEDIA LLC
2024-04-24
FLEX
FLEX
98432467 not registered Live/Pending
Task Force Tips LLC
2024-03-04
FLEX
FLEX
98418322 not registered Live/Pending
Blended BioHealth, Inc.
2024-02-23
FLEX
FLEX
98409113 not registered Live/Pending
Espen Technology Inc
2024-02-16
FLEX
FLEX
98257164 not registered Live/Pending
A. O. Smith Corporation
2023-11-06
FLEX
FLEX
98166400 not registered Live/Pending
Flex-Elektrowerkzeuge GmbH
2023-09-06
FLEX
FLEX
98166387 not registered Live/Pending
Flex-Elektrowerkzeuge GmbH
2023-09-06

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