FDA.reportPublic FDA data

Avalign

Primary DI
00190776160814
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM104-6921
Device description
Sinuscope, angled autoclavable, 70ø, wide, Diameter 4mm, WL 185mm (7 3/8")
Published
2021-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00190776160814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776160814001907761608141907761608140190776160814

GMDN Terms#

Term, Definition table
TermDefinition
Rigid sinoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. 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
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850042909003ProsidioProsidio LLCEOB2026-01-16
00850042909010ProsidioProsidio LLCEOB2026-01-16
00850042909812ProsidioProsidio LLCEOB2026-01-16
00848657076883AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657076890AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657077712AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
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