FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776328368
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
LI-481
Device description
Verres Needle,
Published
2023-09-28
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
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
00190776328368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776328368001907763283681907763283680190776328368

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. 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
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
00810130456147Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456154Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
14026704934598PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
14026704934604PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
14026704934611PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06