FDA.reportPublic FDA data

Millennium

Primary DI
00190776414337
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-3260024E
Device description
"LASER BLACK LEEP DEPTH RULER, 9.45"" (240MM) WL"
Published
2025-10-23
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
HDEHook, Fibroid, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDEHook, Fibroid, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776414337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776414337001907764143371907764143370190776414337

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, reusableA collection of various surgical instruments, dressings, and materials intended to be used during obstetrical/gynaecological surgery. It is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific type of surgical procedure; it does not contain pharmaceuticals. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092732ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506092749ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506092831ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506093869ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506091667ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-10
00190776419271MillenniumAvalign Technologies, Inc.HDE2026-04-14
00198506086069ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-08
00198506072895ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-02
00198506072987ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-02
00198506085819ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-25
00198506085833ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-25
00198506085680ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-18
00198506083235ELMED INCORPORATEDELMED INCORPORATEDHDE2025-05-29
00198506081156ELMED INCORPORATEDELMED INCORPORATEDHDE2025-03-10
G586OB6301180Novo SurgicalNOVO SURGICAL, INC.HDE2023-12-18
G586OB96301210Novo SurgicalNOVO SURGICAL, INC.HDE2023-12-18
00842331193538Novo Surgical Inc. NOVO SURGICAL, INC.HDE2023-12-07
00842331193545Novo Surgical Inc. NOVO SURGICAL, INC.HDE2023-12-07
00840319748350Hayden MedicalHayden Medical, Inc.HDE2023-03-21
00840319748367Hayden MedicalHayden Medical, Inc.HDE2023-03-21
14026704792280PILLINGTELEFLEX INCORPORATEDHDE2022-12-08
54026704792288PILLINGTELEFLEX INCORPORATEDHDE2022-12-08
00842331131370Novo Surgical Inc. NOVO SURGICAL, INC.HDE2022-11-10
00842331131417Novo Surgical Inc. NOVO SURGICAL, INC.HDE2022-11-10
00840306807305Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HDE2022-11-07
00887482074831Symmetry BuieASPEN SURGICAL PRODUCTS, INC.HDE2022-08-24
00190776041717AvalignAvalign Technologies, Inc.HDE2021-11-03
00190776211929AvalignAvalign Technologies, Inc.HDE2021-11-03
00190776176884MillenniumAvalign Technologies, Inc.HDE2021-11-01
00190776176891MillenniumAvalign Technologies, Inc.HDE2021-11-01