SomnoGuard SPX

GUDID 04260383460310

Tomed GmbH

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID04260383460310
NIH Device Record Key9891acba-0217-4a94-af23-0ac0e9ab3526
Commercial Distribution StatusIn Commercial Distribution
Brand NameSomnoGuard SPX
Version Model Number03090000
Company DUNS313000292
Company NameTomed GmbH
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260383460310 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-15

Devices Manufactured by Tomed GmbH

04260383460013 - SomnoGuard SP Soft2018-07-06
04260383460297 - SomnoGuard AP 22018-07-06
04260383460310 - SomnoGuard SPX2018-07-06
04260383460310 - SomnoGuard SPX2018-07-06
04260383460341 - SomnoGuard AP Pro2018-07-06

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