FDA.reportPublic FDA data

Millennium

Primary DI
00190776401139
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-N1685D10
Device description
"Perforating Needle, straight, WL55mm (2 1/8""), OL160mm (6 1/4"")"
Published
2025-06-09
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
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776401139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776401139001907764011391907764011390190776401139

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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456802Medco ManufacturingMedco Manufacturing LLCGDM2026-08-25
00810130456772Medco ManufacturingMedco Manufacturing LLCGDM2026-08-07
14026704760555PILLINGTELEFLEX INCORPORATEDGDM2026-07-31
00810130456543Medco ManufacturingMedco Manufacturing LLCGDM2026-06-26
00348783011340Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011357Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011364Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011371Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00810130456499Medco ManufacturingMedco Manufacturing LLCGDM2026-06-05
00840516145884Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2026-06-02
00810130456376Medco ManufacturingMedco Manufacturing LLCGDM2026-05-29
00810130456383Medco ManufacturingMedco Manufacturing LLCGDM2026-05-29
00810130456307Medco ManufacturingMedco Manufacturing LLCGDM2026-05-07
00810130456345Medco ManufacturingMedco Manufacturing LLCGDM2026-05-07
00810130456260Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130456277Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130456284Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130455645Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455744Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455799Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455805Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455874Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455881Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455898Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455942Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455959Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455966Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456048Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456055Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456079Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31