FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776319557
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-170567
Device description
Middle Ear Mirror, Angled
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTXMirror, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTXMirror, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776319557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776319557001907763195571907763195570190776319557

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgery mirrorA reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.

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
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613105877MSI Precision Specialty InstrumentsMed Saver, Inc.FTX2025-03-21
00887482113974Symmetry HouseASPEN SURGICAL PRODUCTS, INC.FTX2024-08-12
D9436951D0Power Dental USAPower Dental U.S.A. Inc.FTX2023-02-28
D94369640Power Dental USAPower Dental U.S.A. Inc.FTX2023-02-28
D943G69620GargPower Dental U.S.A. Inc.FTX2023-02-28
14026704805171PILLINGTELEFLEX INCORPORATEDFTX2022-12-08
54026704805179PILLINGTELEFLEX INCORPORATEDFTX2022-12-08
D9436968Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-12
D943N6968Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-12
D9436950S0Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D94369540Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D94369690Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436913Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436950S00Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436953Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436954Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436955Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436956Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436969Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6953Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6954Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6955Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6956Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6969Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
00190776044268AvalignAvalign Technologies, Inc.FTX2021-11-03
D943N6952Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.FTX2021-07-17
D943193010Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D9436920BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D94369710Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D9436911BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13