FDA.reportPublic FDA data

Millennium

Primary DI
00190776401764
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-124590001
Device description
"Cobb-Ragde Single Needle, OL 10"", angled 40°, slightly malleable"
Published
2025-06-13
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
GDLNeedle, Suturing, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDLNeedle, Suturing, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776401764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776401764001907764017641907764017640190776401764

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
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397128Millennium85-640041212026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613031718MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613040130MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613054878MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613084950MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112493MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112509MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112622MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112684MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613113308MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119843MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119850MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119874MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119881MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119898MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119911MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121129MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121136MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00190776397715MillenniumAvalign Technologies, Inc.GDL2025-05-16
00194613106218MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613114237MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119867MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119904MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119928MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00190776390716MillenniumAvalign Technologies, Inc.GDL2024-11-19
G586OP7121290Novo SurgicalNOVO SURGICAL, INC.GDL2024-10-15
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