SomnoGuard SP Soft

GUDID 04260383460013

Tomed GmbH

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 04260383460013
• NIH Device Record Key: 5c2978c0-3ff0-453a-aa7b-5dcf6e28d02f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SomnoGuard SP Soft
• Version Model Number: 03070000
• Company DUNS: 313000292
• Company Name: Tomed GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260383460013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121761

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-01

Devices Manufactured by Tomed GmbH

• 04260383460013 - SomnoGuard SP Soft: 2018-07-06
• 04260383460013 - SomnoGuard SP Soft: 2018-07-06
• 04260383460297 - SomnoGuard AP 2: 2018-07-06
• 04260383460310 - SomnoGuard SPX: 2018-07-06
• 04260383460341 - SomnoGuard AP Pro: 2018-07-06