Identity
- Trade Name
- NARVAL CC FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular repositioning device, the Narval CC functions by advancing the lower jaw (mandible) in a forward position during sleep. This acts to increase the patient's pharyngeal space, improving their ability to exchange air and reducing their tendency to snore. FDA UDI
- Model / Reference
- 200002 FDA UDI
- Description
- The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular repositioning device, the Narval CC functions by advancing the lower jaw (mandible) in a forward position during sleep. This acts to increase the patient's pharyngeal space, improving their ability to exchange air and reducing their tendency to snore. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760287780022 FDA UDI
- 510(k) Number
- K113201 FDA UDI
- FDA Product Code
- LQZ FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
Narval Cc by Resmed Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
- Tap III Anti-Snoring Device — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class II
- SML — Selane Products, Inc. · Class II
- SML — Selane Products, Inc. · Class II
- Rest Assured — RANIR LLC · Class II
- EMA — The Myerson Company Limited · Class II
- TAP 1 & 3 — Ortho Solutions LC · Class II
- EMA — The Myerson Company Limited · Class II
- SomnoDent ALPHA — SOMNOMED INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Resmed Corp
Sources (1)
- FDA UDI ea2dec3c-48ae-4f44-a18e-26faa5439ba1 34 fields · synced May 30, 2026