FDA.reportPublic FDA data

Narval CC

Primary DI
00619498020041
Brand
Narval CC
Company
RESMED MOTOR TECHNOLOGIES INC.
Model
200002
Catalog number
200002
Device description
Mandibular Repositioning Device
Published
2016-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LQZDevice, Jaw Repositioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQZDevice, Jaw RepositioningDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498020041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498020041006194980200416194980200410619498020041

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-424-0737reception@resmed.com

Regulatory Flags#

DUNS number
147450258
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498020027Narval CC2000462000462016-09-05
00619498020034Narval CC2000472000472016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860008847539KAVA HERBST DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
D775CSAA0NAPA ApplianceGreat Lakes Dental Technologies, Ltd.LQZ2026-04-13
00860008847508KAVA DORSAL ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
00860008847515KAVA HERBST ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
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