FDA.reportPublic FDA data

Millennium

Primary DI
00190776080600
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
440-640
Device description
Sinuscope, 2.7mm,
Published
2017-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776080600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776080600001907760806001907760806000190776080600

GMDN Terms#

Term, Definition table
TermDefinition
Rigid nasopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26
00190776437114Millennium1-516440-6752026-10-26
00190776437121Millennium1-516450-6752026-10-26
00190776437138Millennium1-516460-6752026-10-26
00190776437145Millennium1-508001H2026-10-26
00190776437152Millennium1-508002H2026-10-26
00190776437169Millennium1-508003H2026-10-26
00190776439743Millenium85-710191572026-10-26
00190776439750Millenium85-650112602026-10-26
00190776439767Millenium85-650112642026-10-26
00190776439774Millenium85-250039002026-10-26
00190776439781Millenium85-530183372026-10-26
00190776439798Millenium85-200803072026-10-26
00190776439804Millenium85-200803122026-10-26
00190776436902Millennium1-5053602026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860006918798ProsidioProsidio LLCEOB2026-10-24
04580826921001PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25