FDA.reportPublic FDA data

Millennium

Primary DI
00190776391386
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-5489-0335-99
Device description
Angular Template, 35
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776391386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776391386001907763913861907763913860190776391386

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286853163TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853170TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853187TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855587TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855921TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859929TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859943TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859967TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859974TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859981TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859998TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860000TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860123Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860130Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860222Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860444Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860468Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860482Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860505Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860529Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860543Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860567Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860581Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860604Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00889024701281Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701298Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701304Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701311Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701328Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701335Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10