FDA.reportPublic FDA data

Avalign

Primary DI
00190776046972
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-1862
Device description
Joseph Nasal Knife,
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
KASKNIFE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KASKnife, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776046972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776046972001907760469721907760469720190776046972

GMDN Terms#

Term, Definition table
TermDefinition
Nasal knifeA hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). 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
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
00190776422622MillenniumAvalign Technologies, Inc.KAS2026-08-03
09348811143594INKAThe Trustee for KAISER FAMILY TRUSTKAS2026-03-18
09348811155153INKAThe Trustee for KAISER FAMILY TRUSTKAS2025-11-28
00810207783169Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783176Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783183Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783190Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783206Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783213Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783220Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783237Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783244Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783251Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00190776414238MillenniumAvalign Technologies, Inc.KAS2025-10-22
00194613047528MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-08-01
04049047120292GimmiGimmi GmbHKAS2025-05-21
04049047120339GimmiGimmi GmbHKAS2025-05-21
04049047120360GimmiGimmi GmbHKAS2025-05-21
04049047120407GimmiGimmi GmbHKAS2025-05-21
00194613100285MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-03-21
00194613089689MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2024-08-15
00194613090821MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2024-08-15
00840306812361Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
00840306812378Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
00840306812385Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
G586E97860210Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
G586E97860220Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
G586E97860230Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
00190776046965AvalignAvalign Technologies, Inc.KAS2023-11-13
00190776224776AvalignAvalign Technologies, Inc.KAS2023-09-28