FDA UDI
In Commercial Distribution
🇺🇸 United States
SnoreByte Tray
DI: B140351951
·
Model: 3519-5
·
Braebon Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- SnoreByte Tray
- Primary DI
- B140351951
- Version / Model
- 3519-5
- Catalog Number
- 3519-5
- Company Name
- Braebon Medical Corporation
- Labeler DUNS
- 251731105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-06-09
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- 1fc25c97-0037-4203-a13c-92027c62ca9f
Device Description
Clear tray, intended for use as a temporary or trial device in the treatment of snoring or obstructive sleep apnea.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47527 | Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis | A removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding and by applying pressure to lift a drooping soft palate, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B140351950 | HIBCC | ||||
| Primary | B140351951 | HIBCC |
Customer Contacts
- Phone
- 6138316690
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082849 | 000 |