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
00190776430955MillenniumFTIMG275612026-09-18
00190776430962Millennium1-262-122026-09-18
00190776430979Millennium1-01151632026-09-18
00190776430986Millennium1-01151682026-09-18
00190776430993Millennium72-240426NR2026-09-18
00190776431006Millennium1-1050922026-09-18
00190776431013Millennium1-492162026-09-18
00190776431020Millennium1-2421050002026-09-18
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429126MillenniumAvalign Technologies, Inc.HAO2026-09-04
00190776423964MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776423995MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428068MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428075MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428082MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428099MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428105MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428112MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776420352MillenniumAvalign Technologies, Inc.HAO2026-08-25
00190776411558MillenniumAvalign Technologies, Inc.HAO2026-08-07
00190776407537MillenniumAvalign Technologies, Inc.HAO2026-08-03
00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00810220800515Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00190776407377MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776407384MillenniumAvalign Technologies, Inc.HAO2026-07-28
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