FDA.reportPublic FDA data

Millennium

Primary DI
00190776423858
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-320P01123
Device description
Hank Uterine Dilator
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776423858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776423858001907764238581907764238580190776423858

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27
00190776424015Millennium85-120121642026-08-27
00190776424022Millennium85-210153622026-08-27
00190776424039Millennium85-220037062026-08-27
00190776424046Millennium85-720391342026-08-27
00190776424084Millennium85-640064342026-08-27
00190776424091Millennium85-760796022026-08-27
00190776424107Millennium85-770087842026-08-27
00190776424114Millennium85-120079002026-08-27
00190776424121Millennium85-660175762026-08-27
00190776424138Millennium85-510124832026-08-27
00190776424145Millennium85-720426312026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427948MillenniumAvalign Technologies, Inc.HDQ2026-08-27
00190776419141MillenniumAvalign Technologies, Inc.HDQ2026-08-23
00190776419608MillenniumAvalign Technologies, Inc.HDQ2026-08-23
00190776419615MillenniumAvalign Technologies, Inc.HDQ2026-08-23
00190776407469MillenniumAvalign Technologies, Inc.HDQ2026-07-31
00198506093180ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00198506093241ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00198506093357ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00860011927686Monarch Medical ProductsBioteque Taiwan Ltd.HDQ2026-07-24
04719894436517LTL MedicalBioteque Taiwan Ltd.HDQ2026-07-24
00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093708ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093715ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093722ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092473ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092480ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092497ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00348783011265Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011272Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011289Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08