FDA.reportPublic FDA data

Avalign

Primary DI
00190776049355
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM106-9136
Device description
Tyding 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
00190776049355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776049355001907760493551907760493550190776049355

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
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
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