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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

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