FDA.reportPublic FDA data

Millennium

Primary DI
00190776419325
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-124090012-9
Device description
"McCREA FEMALE SOUND 9"" OL 12FR"
Published
2026-04-14
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
HHMSound, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776419325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776419325001907764193251907764193250190776419325

GMDN Terms#

Term, Definition table
TermDefinition
Uterine sound, reusableA hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device intended to be sterilized prior to use.

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
00190776405892MillenniumAvalign Technologies, Inc.HHM2026-07-26
00860011927617Monarch Medical ProductsBioteque Taiwan Ltd.HHM2026-07-24
04719894436524LTL MedicalBioteque Taiwan Ltd.HHM2026-07-24
00190776421618MillenniumAvalign Technologies, Inc.HHM2026-06-23
00190776408442MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419295MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419301MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419318MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419332MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419356MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419363MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419370MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776413361MillenniumAvalign Technologies, Inc.HHM2025-10-09
00194613017545MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613085841MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613111083MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00190776405670MillenniumAvalign Technologies, Inc.HHM2025-07-18
00190776405687MillenniumAvalign Technologies, Inc.HHM2025-07-18
04049047110064GimmiGimmi GmbHHHM2025-05-27
04049047110071GimmiGimmi GmbHHHM2025-05-27
04049047110088GimmiGimmi GmbHHHM2025-05-27
04049047110095GimmiGimmi GmbHHHM2025-05-27
04049047110101GimmiGimmi GmbHHHM2025-05-27
04049047110118GimmiGimmi GmbHHHM2025-05-27
04049047110125GimmiGimmi GmbHHHM2025-05-27
04049047110132GimmiGimmi GmbHHHM2025-05-27
04049047110149GimmiGimmi GmbHHHM2025-05-27
04049047110156GimmiGimmi GmbHHHM2025-05-27
04049047110163GimmiGimmi GmbHHHM2025-05-27
04049047110170GimmiGimmi GmbHHHM2025-05-27