FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications

CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776080600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776080600001907760806001907760806000190776080600

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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00850042909010ProsidioProsidio LLCEOB2026-01-16
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00848657076883AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657076890AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657077712AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
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00848657078146AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
04961333255191VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255245VIVIDEOHOYA CORPORATIONEOB2025-12-19
00850042909027ProsidioProsidio LLCEOB2025-12-05
00850042909034ProsidioProsidio LLCEOB2025-12-05
00850042909041ProsidioProsidio LLCEOB2025-12-05
00850042909058ProsidioProsidio LLCEOB2025-12-05
00850042909065ProsidioProsidio LLCEOB2025-12-05
00850042909072ProsidioProsidio LLCEOB2025-12-05
00850042909089ProsidioProsidio LLCEOB2025-12-05
00850042909096ProsidioProsidio LLCEOB2025-12-05
00850042909102ProsidioProsidio LLCEOB2025-12-05
00850042909119ProsidioProsidio LLCEOB2025-12-05
00850042909126ProsidioProsidio LLCEOB2025-12-05
00850042909133ProsidioProsidio LLCEOB2025-12-05
00850042909140ProsidioProsidio LLCEOB2025-12-05
00850042909157ProsidioProsidio LLCEOB2025-12-05
00850042909164ProsidioProsidio LLCEOB2025-12-05
00850042909171ProsidioProsidio LLCEOB2025-12-05
00850042909188ProsidioProsidio LLCEOB2025-12-05
00850042909195ProsidioProsidio LLCEOB2025-12-05
00850042909201ProsidioProsidio LLCEOB2025-12-05
00850042909829ProsidioProsidio LLCEOB2025-12-05