FDA.reportPublic FDA data

Millennium

Primary DI
00190776177300
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-7062
Device description
WEISMAN-GRAVES SPEC R LGE .
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
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776177300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776177300001907761773001907761773000190776177300

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.

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
00190776418274MillenniumAvalign Technologies, Inc.HDF2026-03-23
B356JB543320American MedicalsAmerican MedicalsHDF2026-02-26
00198506088810ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-25
00198506088773ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00198506088780ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00190776416164MillenniumAvalign Technologies, Inc.HDF2026-02-06
00190776416171MillenniumAvalign Technologies, Inc.HDF2026-02-06
B356JB641170American MedicalsAmerican MedicalsHDF2026-02-06
00190776415594MillenniumAvalign Technologies, Inc.HDF2026-01-28
00190776415259MillenniumAvalign Technologies, Inc.HDF2026-01-27
00190776415266MillenniumAvalign Technologies, Inc.HDF2026-01-27
00198506088278ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-27
00198506087752ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087769ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087202ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-18
00198506087066ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-17
00190776415136MillenniumAvalign Technologies, Inc.HDF2025-12-03
00810158218062PRINCETONPrinceton Medical Group, Inc.HDF2025-11-17
M803030915Kogan 2-4mm w/screwMEDGYN PRODUCTS, INC.HDF2025-11-16
00198506067815ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506067822ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506068324ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00190776410650MillenniumAvalign Technologies, Inc.HDF2025-09-11
00198506085161ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-05
00190776409258MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776409289MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776408589MillenniumAvalign Technologies, Inc.HDF2025-08-19
00190776407995MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408008MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408077MillenniumAvalign Technologies, Inc.HDF2025-08-06