FDA.reportPublic FDA data

Millennium

Primary DI
00190776166496
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-350149
Device description
DESMARRES LID RETR
Published
2021-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776166496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776166496001907761664961907761664960190776166496

GMDN Terms#

Term, Definition table
TermDefinition
Telemetric sphygmomanometerAn electrically-powered device designed to noninvasively measure blood pressure by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may in addition measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements can be wirelessly sent to a medical facility for analysis, typically using a computer or mobile phone with a dedicated software.

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
00190776411084Millennium85-780816802026-08-07
00190776411091Millennium85-590091642026-08-07
00190776411107Millennium85-428459942026-08-07
00190776411473Millennium85-420410542026-08-07
00190776411480Millennium85-720471982026-08-07
00190776411497Millennium85-510046232026-08-07
00190776411503Millennium85-320020492026-08-07
00190776411510Millennium85-520016892026-08-07
00190776411527Millennium85-520062662026-08-07
00190776411534Millennium85-400463172026-08-07
00190776411541Millennium85-650098522026-08-07
00190776411558Millennium85-650123692026-08-07
00190776411565Millennium85-170121992026-08-07
00190776411572Millennium85-210785222026-08-07
00190776411589Millennium85-600016902026-08-07
00190776423544Millennium1-263T2026-08-07
00190776423551Millennium63-G122582026-08-07
00190776423568Millennium72-4535040E2026-08-07
00190776423575Millennium1-1201492026-08-07
00190776423582Millennium1-43098252026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423551MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423742MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423759MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423766MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423773MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423780MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424411MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424428MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424442MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424480MillenniumAvalign Technologies, Inc.GAD2026-08-07
B382SD484600Surgical DirectSurgical Direct, Inc.GAD2026-08-07
G4533315010BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-07
G4533315012BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-07
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30