FDA.reportPublic FDA data

Millennium

Primary DI
00190776409708
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-1600W
Device description
"Laminaria Insertion Forceps 10"""
Published
2025-09-08
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
HDAForceps, Obstetrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDAForceps, ObstetricalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776409708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776409708001907764097081907764097080190776409708

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
00190776411084Millennium85-780816802026-08-07
00190776411091Millennium85-590091642026-08-07
00190776411107Millennium85-428459942026-08-07
00190776411473Millennium85-420410542026-08-07
00190776411480Millennium85-720471982026-08-07
00190776411497Millennium85-510046232026-08-07
00190776411503Millennium85-320020492026-08-07
00190776411510Millennium85-520016892026-08-07
00190776411527Millennium85-520062662026-08-07
00190776411534Millennium85-400463172026-08-07
00190776411541Millennium85-650098522026-08-07
00190776411558Millennium85-650123692026-08-07
00190776411565Millennium85-170121992026-08-07
00190776411572Millennium85-210785222026-08-07
00190776411589Millennium85-600016902026-08-07
00190776423544Millennium1-263T2026-08-07
00190776423551Millennium63-G122582026-08-07
00190776423568Millennium72-4535040E2026-08-07
00190776423575Millennium1-1201492026-08-07
00190776423582Millennium1-43098252026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776419196MillenniumAvalign Technologies, Inc.HDA2026-04-13
00190776416119MillenniumAvalign Technologies, Inc.HDA2026-02-06
00194613119683MSI Precision Specialty InstrumentsMed Saver, Inc.HDA2025-08-01
00190776406271MillenniumAvalign Technologies, Inc.HDA2025-07-21
00850071684261Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684278Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684285Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684292Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00190776387969MillenniumAvalign Technologies, Inc.HDA2024-11-12
00190776387075MillenniumAvalign Technologies, Inc.HDA2024-09-06
00190776384883MillenniumAvalign Technologies, Inc.HDA2024-08-26
00887482030196Symmetry AuvardASPEN SURGICAL PRODUCTS, INC.HDA2024-08-07
00887482043585Symmetry DeLeeASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482043615Symmetry Kielland-LuikartASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078877Symmetry ElliotASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078914Symmetry KiellandASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078976Symmetry BartonASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00840183505509BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00840183513344BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00190776127640MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776142698MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776143886MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776250744AvalignAvalign Technologies, Inc.HDA2023-11-13
00190776250089AvalignAvalign Technologies, Inc.HDA2023-09-28
00190776296797MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00190776371241MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00810123206148Adler Instrument CompanyAdler, Inc.HDA2023-08-24
00190776369125MillenniumAvalign Technologies, Inc.HDA2023-04-03
00840319750346Hayden MedicalHayden Medical, Inc.HDA2023-03-21
00840319750353Hayden MedicalHayden Medical, Inc.HDA2023-03-21