FDA.reportPublic FDA data

Millennium

Primary DI
00190776428143
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-030637
Device description
Sims Curette, Sharp, 11", Malleable, #8
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00190776428143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776428143001907764281431907764281430190776428143

GMDN Terms#

Term, Definition table
TermDefinition
Endaural surgical curette, reusableA slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade 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
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
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
10195594623807CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-24
10195594715830CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23