FDA.reportPublic FDA data

Millennium

Primary DI
00190776423872
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-20094976
Device description
Ear Syringe, 100cc (3oz)
Published
2026-08-26
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776423872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776423872001907764238721907764238720190776423872

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation syringeA device intended to be used to flush the ear canal with an irrigating solution. It is typically available in two main design mechanisms that are used to carefully exert pressure on the irrigating fluid: 1) a cylindrical barrel with a plunger that have finger and thumb rings respectively mounted onto them for the operator to apply the necessary pressure; and 2) an elastomeric rubber, one-piece bulb that tapers to a thin nozzle that fits into the outer ear canal. This device may be used by a healthcare professional or by the patient/end user. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
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
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27
00190776424015Millennium85-120121642026-08-27
00190776424022Millennium85-210153622026-08-27
00190776424039Millennium85-220037062026-08-27
00190776424046Millennium85-720391342026-08-27
00190776424084Millennium85-640064342026-08-27
00190776424091Millennium85-760796022026-08-27
00190776424107Millennium85-770087842026-08-27
00190776424114Millennium85-120079002026-08-27
00190776424121Millennium85-660175762026-08-27
00190776424138Millennium85-510124832026-08-27
00190776424145Millennium85-720426312026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427979MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428013MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428136MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428204MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428235MillenniumAvalign Technologies, Inc.LRW2026-08-27
00192896123649Converse ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00192896123656Ferguson Abdominal ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00190776423865MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776427634MillenniumAvalign Technologies, Inc.LRW2026-08-26
00846159040845SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040852SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040869SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00190776420383MillenniumAvalign Technologies, Inc.LRW2026-08-25
04058749006032NAFehling Instruments GmbH & Co. KGLRW2026-08-25
04058749047219NAFehling Instruments GmbH & Co. KGLRW2026-08-25
00190776427283MillenniumAvalign Technologies, Inc.LRW2026-08-21
04054462903290evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904624evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904631evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904655evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904679evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904723evonosevonos GmbH & Co. KGLRW2026-08-21
04054462907892evonosevonos GmbH & Co. KGLRW2026-08-21
04054462907915evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908196evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908202evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908219evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908226evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908233evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908257evonosevonos GmbH & Co. KGLRW2026-08-21