FDA.reportPublic FDA data

Avalign

Primary DI
00190776047955
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-1817
Device description
Joseph Bay Saw, angled right
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDRSAW, MANUAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776047955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776047955001907760479551907760479550190776047955

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
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
08403207009517Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
08403207009579Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
04049047061984GimmiGimmi GmbHGDR2025-05-20
04049047062080GimmiGimmi GmbHGDR2025-05-20
00810123208593Adler Instrument CompanyAdler, Inc.GDR2025-02-12
04049197537292RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-10-16
04049197499248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499262RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197149983RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197149990RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150002RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150125RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150163RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205146RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205153RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
00190776385774MillenniumAvalign Technologies, Inc.GDR2024-05-09
00842517107533Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00842517107540Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00888515192003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192010BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192027BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192034BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192058BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192065BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192072BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192089BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192096BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515201927BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515201965BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28