FDA.reportPublic FDA data

Millennium

Primary DI
00190776295226
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-702S12
Device description
HEGAR DILATOR SINGLE END
Published
2022-12-12
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
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
00190776295226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776295226001907762952261907762952260190776295226

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
+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
G586NSGU40600160Novo SurgicalNOVO SURGICAL, INC.HDQ2024-03-08
GYNX42111GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42121GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42131GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42211GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42221GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42231GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42401GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42451GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42501GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42551GynexGYNEX CORPORATIONHDQ2023-12-19
08800142923982V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924019V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924040V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924071V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924101V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924132V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
07898506815050QuinelatoSchobell Industrial LtdaHDQ2023-01-09
07899798202634SchobellSchobell Industrial LtdaHDQ2023-01-09
10653160351276CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-03-28
10653160351283CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-03-28
10653160351290CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-03-28
10653160314332CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-01-01
10381780509363Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780509370Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780500728Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500735Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500742Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500759Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500766Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18