FDA.reportPublic FDA data

Millennium

Primary DI
00190776169619
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-775-3
Device description
Needle Extender
Published
2021-11-01
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
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776169619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776169619001907761696191907761696190190776169619

GMDN Terms#

Term, Definition table
TermDefinition
Luer needle extenderA slim, rigid tube intended to connect to a Luer needle to extend the length of the needle for access to anatomical sites that a standard length needle might not reach. It has a Luer connection at each end and does not incorporate any additional functionality. 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
00190776405960Millennium85-100042892026-07-28
00190776405977Millennium85-230675282026-07-28
00190776407285Millennium85-250064102026-07-28
00190776407292Millennium85-250050002026-07-28
00190776407308Millennium85-070840962026-07-28
00190776407315Millennium85-510045332026-07-28
00190776407322Millennium85-670337972026-07-28
00190776407346Millennium85-140080412026-07-28
00190776407353Millennium85-220032842026-07-28
00190776407360Millennium85-420461622026-07-28
00190776407377Millennium85-671351502026-07-28
00190776407384Millennium85-580058692026-07-28
00190776422080Millennium72-37180032026-07-28
00190776422158Millennium1-2701802026-07-28
00190776422165Millennium72-3217125I2026-07-28
00190776422172Millennium1-20524572026-07-28
00190776422189Millennium1-633522026-07-28
00190776422196Millennium1-3202392026-07-28
00190776422202Millennium1-ASIM123205262026-07-28
00190776404093Millennium85-670332562026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084501012Xpansion® Micro-Autografting KitNEW HORIZON HEALTHCARE MANAGEMENT LLCGDF2026-07-28
06976712970334Hemo NeedleMicro-Energy Medical Technology Co., LtdGDF2026-07-13
04048223069738TunnEler 235Pajunk GmbH MedizintechnologieGDF2026-06-10
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199534132Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534149Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534156Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534163Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534170Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534187Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534194Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01