FDA.reportPublic FDA data

Millennium

Primary DI
00190776413064
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-19190
Device description
LATHBURY APPLICATOR 5.5 TRIANGULAR TIP
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776413064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776413064001907764130641907764130640190776413064

GMDN Terms#

Term, Definition table
TermDefinition
ENT powder applicatorAn applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776436902Millennium1-5053602026-10-23
00190776436919Millennium1-3994896SS2026-10-23
00190776436926Millennium1-3110196SS2026-10-23
00190776436933Millennium1-3139696SS2026-10-23
00190776436940Millennium1-399481SS2026-10-23
00190776436957Millennium1-45382026-10-23
00190776436964Millennium72-321001IM2026-10-23
00190776436971Millennium72-321002IM2026-10-23
00190776436988Millennium72-321003IM2026-10-23
00190776436995Millennium1-3417302026-10-23
00190776437008Millennium72-1371112026-10-23
00190776437015Millennium1-MPR1049012026-10-23
00190776437022Millennium1-MPR1049022026-10-23
00190776437039Millennium92-F2710CT2026-10-23
00190776437046Millennium92-F2050T2026-10-23
00190776437053Millennium92-F2710T2026-10-23
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423070MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435813MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435820MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435837MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435844MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435851MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435868MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436735MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436742MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436759MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25