FDA.reportPublic FDA data

Millennium

Primary DI
00190776368067
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-754-4-14M
Device description
"SIMS UTERINE CURETTE #4 SHARP/MALLEABLE 14"""
Published
2023-02-20
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
HCYCURETTE, UTERINE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776368067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776368067001907763680671907763680670190776368067

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956562455CARDINAL HEALTHCardinal Health 200, LLCHCY2026-09-21
00190776428143MillenniumAvalign Technologies, Inc.HCY2026-08-27
00190776417178MillenniumAvalign Technologies, Inc.HCY2026-08-19
10198956499843CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-27
10198956535367CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-27
10198956395497CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-20
10198956532632CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-20
10198956360112CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-16
10198956440456CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-16
10198956495012CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-16
00190776395636MillenniumAvalign Technologies, Inc.HCY2026-07-14
10198956388789CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-06
00850083275464Intrace USAPILOTIS TECH LLCHCY2026-07-03
00850083275488Intrace USAPILOTIS TECH LLCHCY2026-07-03
00198506091537ELMED INCORPORATEDELMED INCORPORATEDHCY2026-06-10
00198506091544ELMED INCORPORATEDELMED INCORPORATEDHCY2026-06-10
10198956475366CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-05
10198956366428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
10198956476530CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
07898506815111QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815135QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815159QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815319QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815333QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815340QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815357QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815364QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506840922QuinelatoSchobell Industrial LtdaHCY2023-01-09
10195594684549CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594685485CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-08