SomnoDent AVANT

GUDID 00851826007243

SomnoDent Avant Strap Set L

SOMNOMED, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851826007243
• NIH Device Record Key: c0a63420-71b1-47c3-82dd-90ade343c6fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SomnoDent AVANT
• Version Model Number: AVANT Strap LARGE
• Company DUNS: 623527962
• Company Name: SOMNOMED, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 888-447-6673
• Email: customerservice@somnomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851826007243 [Primary]

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-06
• Device Publish Date: 2019-08-29

On-Brand Devices [SomnoDent AVANT]

• 00851826007243: SomnoDent Avant Strap Set L
• 00851826007236: SomnoDent AVANT Strap Set Medium
• 00851826007229: SomnoDent AVANT Strap Set Small
• 00851826007212: SomnoDent Avant kit with Small Strap Set
• 00851826007205: SomnoDent Avant kit with Medium Strap Set
• 00851826007199: SomnoDent Avant kit with Large Strap Set
• 00851826007342: SomnoDent AVANT Strap Kit D
• 00851826007335: SomnoDent AVANT Strap Kit C
• 00851826007328: SomnoDent AVANT Strap Kit B
• 00851826007311: SomnoDent AVANT Strap Kit A
• 00851826007304: SomnoDent AVANT with Strap Kit C
• 00851826007298: SomnoDent AVANT with Strap Kit B
• 00851826007281: SomnoDent AVANT with Strap Kit A