FDA.reportPublic FDA data

Avalign

Primary DI
00190776032531
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM87-1111
Device description
Shunt Passer
Published
2017-05-01
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
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776032531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776032531001907760325311907760325310190776032531

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament tunnellerA long, hand-held, manual surgical instrument designed to tunnel an artificial passageway along ligament and/or tendon tissue to create a connecting channel. It can have a variety of designs: 1) a long, round, stiff rod that tapers to a rounded point at the distal tip with a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue; or 2) a ring-handled instrument with long, slightly curved arms that join at a pivot point near the distal end, terminating in short grasping arms. It will typically be 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
00190776404093Millennium85-670332562026-07-24
00190776404109Millennium85-670332512026-07-24
00190776404116Millennium85-670332762026-07-24
00190776404123Millennium85-670332662026-07-24
00190776404130Millennium85-670332712026-07-24
00190776404147Millennium85-200831492026-07-24
00190776404178Millennium85-520033262026-07-24
00190776404185Millennium85-510002082026-07-24
00190776404192Millennium85-750802482026-07-24
00190776404208Millennium85-200801322026-07-24
00190776404215Millennium85-200801372026-07-24
00190776404222Millennium85-420472272026-07-24
00190776404239Millennium85-140181602026-07-24
00190776405748Millennium85-428302392026-07-24
00190776405755Millennium2-74002026-07-24
00190776405762Millennium85-780694882026-07-24
00190776405779Millennium85-530180862026-07-24
00190776405786Millennium85-770111652026-07-24
00190776405793Millennium85-780703032026-07-24
00190776405809Millennium85-250081402026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404109MillenniumAvalign Technologies, Inc.HAO2026-07-24
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404031MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404048MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404055MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404062MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404079MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776400262MillenniumAvalign Technologies, Inc.HAO2026-07-21
00190776400545MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776402105MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776400286MillenniumAvalign Technologies, Inc.HAO2026-07-17
04058749078794NAFehling Instruments GmbH & Co. KGHAO2026-07-17
00190776400231MillenniumAvalign Technologies, Inc.HAO2026-07-16
00190776395445MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395735MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395742MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395759MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395391MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395407MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395414MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395421MillenniumAvalign Technologies, Inc.HAO2026-07-13
04946329056440CEA Scissors 170 mm, 35 deg. Downward CvdMIZUHO CORPORATIONHAO2026-05-29
04946329056457CEA Scissors 180 mm, Sideward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056471CEA Thin Needle Holder 170 mmMIZUHO CORPORATIONHAO2026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29