FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776354619
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
9-53785011
Device description
Needle Diss, semi-sharp, #11
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
HASNEEDLE, NEUROSURGICAL SUTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HASNeedle, Neurosurgical SutureNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776354619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776354619001907763546191907763546190190776354619

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. 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
00190776411084Millennium85-780816802026-08-07
00190776411091Millennium85-590091642026-08-07
00190776411107Millennium85-428459942026-08-07
00190776411473Millennium85-420410542026-08-07
00190776411480Millennium85-720471982026-08-07
00190776411497Millennium85-510046232026-08-07
00190776411503Millennium85-320020492026-08-07
00190776411510Millennium85-520016892026-08-07
00190776411527Millennium85-520062662026-08-07
00190776411534Millennium85-400463172026-08-07
00190776411541Millennium85-650098522026-08-07
00190776411558Millennium85-650123692026-08-07
00190776411565Millennium85-170121992026-08-07
00190776411572Millennium85-210785222026-08-07
00190776411589Millennium85-600016902026-08-07
00190776423544Millennium1-263T2026-08-07
00190776423551Millennium63-G122582026-08-07
00190776423568Millennium72-4535040E2026-08-07
00190776423575Millennium1-1201492026-08-07
00190776423582Millennium1-43098252026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494463051N/ADoppkon GmbH & Co. KGHAS2025-12-04
00887482103579Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-09-05
00887482103593Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-08-01
00190776355067MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
14026704796929PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
54026704796927PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
00887482096215Symmetry AdsonASPEN SURGICAL PRODUCTS, INC.HAS2022-08-24
00190776068585AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776068592AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776211912AvalignAvalign Technologies, Inc.HAS2021-11-03
00190660121549Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660121556Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660109707Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121563Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121570Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
10885403072819V. MuellerSTERIS CORPORATIONHAS2018-08-30