FDA.reportPublic FDA data

Millennium

Primary DI
00190776389215
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-23171675
Device description
2 pc Shunt Passer w/ T-Handle and female luer, Cannula: 4.2mm OD, 3.6mm ID, 75cm WL, Probe: 3.5mm dia at tip, 75cm WL, Reusable Stainless Steel, 77cm OL
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIYStainless Steel Instrument, Shunt System Implantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIYStainless Steel Instrument, Shunt System ImplantationNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776389215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776389215001907763892151907763892150190776389215

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, reusableA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.

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
00198506090875ELMED INCORPORATEDELMED INCORPORATEDPIY2026-05-18
00190776421007MillenniumAvalign Technologies, Inc.PIY2026-04-30
00190776410841MillenniumAvalign Technologies, Inc.PIY2025-09-12
00190776410858MillenniumAvalign Technologies, Inc.PIY2025-09-12
00198506085062ELMED INCORPORATEDELMED INCORPORATEDPIY2025-09-05
00190776401900MillenniumAvalign Technologies, Inc.PIY2025-06-16
00198506082917ELMED INCORPORATEDELMED INCORPORATEDPIY2025-05-22
00190776395957MillenniumAvalign Technologies, Inc.PIY2025-05-09
00198506082511ELMED INCORPORATEDELMED INCORPORATEDPIY2025-04-30
00198506081958ELMED INCORPORATEDELMED INCORPORATEDPIY2025-04-07
00198506075469ELMED INCORPORATEDELMED INCORPORATEDPIY2025-02-20
00198506061325ELMED INCORPORATEDELMED INCORPORATEDPIY2024-09-11
00198506061110ELMED INCORPORATEDELMED INCORPORATEDPIY2024-09-05
00842180199408ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199415ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199422ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199446ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199453ELMEDELMED INCORPORATEDPIY2024-04-23
00842180197732ELMEDELMED INCORPORATEDPIY2024-04-18
00842180192096ELMEDELMED INCORPORATEDPIY2024-04-16
00842180192102ELMEDELMED INCORPORATEDPIY2024-04-16
00842180187382ELMEDELMED INCORPORATEDPIY2024-03-06
00190776299484MillenniumAvalign Technologies, Inc.PIY2023-11-15
00190776300630MillenniumAvalign Technologies, Inc.PIY2023-11-15
00190776301088MillenniumAvalign Technologies, Inc.PIY2023-11-15
00190776376123MillenniumAvalign Technologies, Inc.PIY2023-09-08
00842180175624ELMEDELMED INCORPORATEDPIY2023-08-08
00842180175631ELMEDELMED INCORPORATEDPIY2023-08-08
00842180163546ELMEDELMED INCORPORATEDPIY2023-04-06
00842180164826ELMEDELMED INCORPORATEDPIY2023-03-10