FDA.reportPublic FDA data

Millennium

Primary DI
00190776416164
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-321211IV
Device description
"Insulated Weisman Pederson Vaginal Speculum Right Side Open Small w/ Smoke Tube 3"" x 1/2"" "
Published
2026-02-06
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
HDFSpeculum, Vaginal, Metal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776416164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776416164001907764161641907764161640190776416164

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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275365Intrace USAPILOTIS TECH LLCHDF2026-07-03
00190776421632MillenniumAvalign Technologies, Inc.HDF2026-06-23
00810158211360PRINCETONPrinceton Medical Group, Inc.HDF2026-06-23
05060212052339Cusco Specula Metal SmallDTR MEDICAL LIMITEDHDF2026-06-10
05060212052346Cusco Specula Metal MediumDTR MEDICAL LIMITEDHDF2026-06-10
05060212052360Cusco Specula Metal LargeDTR MEDICAL LIMITEDHDF2026-06-10
05060411982314Cusco Specula Metal Large LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982321Cusco Specula Metal Large Extra LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982369Cusco Specula Metal BroadDTR MEDICAL LIMITEDHDF2026-06-10
05060411984462Cusco Specula Metal Medium LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411985117Cusco Specula Metal Small XXLongDTR MEDICAL LIMITEDHDF2026-06-10
00198506091490ELMED INCORPORATEDELMED INCORPORATEDHDF2026-06-09
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