FDA.reportPublic FDA data

Avalign

Primary DI
00190776210786
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM88-4179
Device description
Liston Amputation Knife,
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
GDNKNIFE, AMPUTATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDNKnife, AmputationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776210786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776210786001907762107861907762107860190776210786

GMDN Terms#

Term, Definition table
TermDefinition
Amputation knifeA hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument made of high-grade stainless steel. 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
B356FF701020American MedicalsAmerican MedicalsGDN2026-07-14
B356BH414050American MedicalsAmerican MedicalsGDN2026-05-06
14026704941640PILLINGTELEFLEX INCORPORATEDGDN2026-03-23
24026704941647PILLINGTELEFLEX INCORPORATEDGDN2026-03-23
14026704941657PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
24026704941654PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
08403207009500Anmuth Medical InternationalAnmuth Medical International, LLCGDN2025-06-09
00840343725563GEN2SURGIX MEDICAL LLCGDN2025-02-11
B356EE173000American MedicalsAmerican MedicalsGDN2024-11-12
04049197022613RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022637RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022644RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022651RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022668RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022675RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197410540RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
B356126CL120American MedicalsAmerican MedicalsGDN2024-05-14
G586N91281280Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
G586N91281310Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
00190776062033AvalignAvalign Technologies, Inc.GDN2023-09-28
00190776289218MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
00190776343408MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
B356BH420280American MedicalsAmerican MedicalsGDN2023-09-28
00810123205929Adler Instrument CompanyAdler, Inc.GDN2023-06-16
00842962107140HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842962160565HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842331143984Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-11
00842331134623Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-10
B35607423200American MedicalsAmerican MedicalsGDN2022-09-21
B35607423240American MedicalsAmerican MedicalsGDN2022-09-21