FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776326937
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-6377
Device description
Eve Tonsil Snare,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBZSNARE, TONSIL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBZSnare, TonsilEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776326937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776326937001907763269371907763269370190776326937

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil snareA manual surgical instrument inserted into the oral cavity to remove the tonsils during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the root of the tonsil to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
20757770455878Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457803Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457810Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457827Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457834Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457841Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
00194613011550MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613048983MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613090739MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613097950MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613121037MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613121044MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00757770413003Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
00757770420629Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
00757770433995Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
04049047127918GimmiGimmi GmbHKBZ2025-05-21
04049047127925GimmiGimmi GmbHKBZ2025-05-21
00194613104566MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-03-21
00887482030059Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482030066Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482030073Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482049204Symmetry EveASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482122891Symmetry EveASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482122914Symmetry TydingASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482122938SymmetryASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482192740Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482192856Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00888515248403BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248489BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248496BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28