FDA.reportPublic FDA data

Avalign

Primary DI
00190776047009
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM104-1881
Device description
Joseph Button End Knife,
Published
2021-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00190776047009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776047009001907760470091907760470090190776047009

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
00190776046972AvalignAvalign Technologies, Inc.KAS2023-09-28
00190776224776AvalignAvalign Technologies, Inc.KAS2023-09-28
00190776224783AvalignAvalign Technologies, Inc.KAS2023-09-28
00190776323349MILLENNIUMAvalign Technologies, Inc.KAS2023-09-28
00190776323356MILLENNIUMAvalign Technologies, Inc.KAS2023-09-28