FDA.reportPublic FDA data

Millennium

Primary DI
00190776298869
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-2412923CSS
Device description
AV Fistula Tunneler 23cm Curved Shaft, Autoclavable Medical Grade Stainless Steel
Published
2022-12-12
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776298869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776298869001907762988691907762988690190776298869

GMDN Terms#

Term, Definition table
TermDefinition
Fistula probeA slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula. 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
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
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04
00190776427993MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776428167MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776427559MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427665MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427740MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427764MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427771MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427788MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427795MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776420369MillenniumAvalign Technologies, Inc.GEN2026-08-25
00190776418236MillenniumAvalign Technologies, Inc.GEN2026-08-23
00190776427238MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427269MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427276MillenniumAvalign Technologies, Inc.GEN2026-08-21
B382SD914775290Surgical DirectSurgical Direct, Inc.GEN2026-08-21
00190776417727MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776426767MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776417109MillenniumAvalign Technologies, Inc.GEN2026-08-18
00198506094002ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00198506094057ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00190776425838MillenniumAvalign Technologies, Inc.GEN2026-08-17
G453333630140PEAK MEDICALPeak Medical Distribution Inc.GEN2026-08-14
00190776423544MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776423735MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776424404MillenniumAvalign Technologies, Inc.GEN2026-08-07
B382SD9238971100Surgical DirectSurgical Direct, Inc.GEN2026-08-07
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03