FDA.reportPublic FDA data

Millennium

Primary DI
00190776394356
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-452110
Device description
"Cone Ventricular Needle, 3 1/2"" (89mm) WL, 2 distal holes, 13g"
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCDCannula, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCDCannula, VentricularNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776394356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776394356001907763943561907763943560190776394356

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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
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
00840343727574Gen2SURGIX MEDICAL LLCHCD2026-04-23
00850047354716ClearPointClearpoint Neuro, Inc.HCD2026-03-10
00198506085031ELMED INCORPORATEDELMED INCORPORATEDHCD2025-09-05
00190776403003MillenniumAvalign Technologies, Inc.HCD2025-06-30
00190776401603MillenniumAvalign Technologies, Inc.HCD2025-06-11
00190776394325MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394332MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394363MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394370MillenniumAvalign Technologies, Inc.HCD2025-05-07
00198506056697ELMED INCORPORATEDELMED INCORPORATEDHCD2025-01-27
00198506056680ELMED INCORPORATEDELMED INCORPORATEDHCD2024-10-29
G586N688847C0Novo SurgicalNOVO SURGICAL, INC.HCD2024-10-15
00198506061356ELMED INCORPORATEDELMED INCORPORATEDHCD2024-09-11
00198506061363ELMED INCORPORATEDELMED INCORPORATEDHCD2024-09-11
00842180154018ELMEDELMED INCORPORATEDHCD2024-08-05
00198506060120ELMEDELMED INCORPORATEDHCD2024-07-23
00198506059568ELMEDELMED INCORPORATEDHCD2024-07-08
00198506058707ELMEDELMED INCORPORATEDHCD2024-07-05
00198506058325ELMEDELMED INCORPORATEDHCD2024-06-10
00842180199002ELMEDELMED INCORPORATEDHCD2024-04-23
00842180197855ELMEDELMED INCORPORATEDHCD2024-04-18
00842180197862ELMEDELMED INCORPORATEDHCD2024-04-18
00842180197879ELMEDELMED INCORPORATEDHCD2024-04-18
G586N6888300Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
G586N6888420Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
G586N6888430Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
00842180179356ELMEDELMED INCORPORATEDHCD2023-10-05
00842180177253ELMEDELMED INCORPORATEDHCD2023-09-14
00190776373436MillenniumAvalign Technologies, Inc.HCD2023-06-23
00842180166936ELMEDELMED INCORPORATEDHCD2023-04-21