SomnoDent AVANT
GUDID 00851826007342
SomnoDent AVANT Strap Kit D
SOMNOMED, INC.
Mandible-repositioning sleep-disordered breathing orthosis| Primary Device ID | 00851826007342 |
| NIH Device Record Key | f19ac018-1a4f-4845-94c0-86dded33261a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SomnoDent AVANT |
| Version Model Number | AVANT Strap Kit D |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com | |
| Phone | 888-447-6673 |
| customerservce@somnomed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851826007342 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183443
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 | 2024-08-22 |
| Device Publish Date | 2024-08-14 |
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 |
Trademark Results [SomnoDent AVANT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNODENT AVANT 79251124 not registered Live/Pending |
SomnoMed Limited 2018-12-24 |
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