FDA.reportPublic FDA data

Millennium

Primary DI
00190776379155
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-S7587
Device description
Saddle Punch, Shaft Length 24 cm, Punch 16.5mm x 6.5mm
Published
2023-10-16
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
HWPPunch, Femoral Neck

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWPPunch, Femoral NeckOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776379155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776379155001907763791551907763791550190776379155

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. 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
00190776407537Millennium85-900114502026-08-03
00190776407544Millennium85-220032892026-08-03
00190776407551Millennium85-200771242026-08-03
00190776407568Millennium85-440133392026-08-03
00190776408619Millennium9-8123302026-08-03
00190776408626Millennium85-500021432026-08-03
00190776408633Millennium85-528030162026-08-03
00190776408640Millennium85-668484472026-08-03
00190776408664Millennium85-650059602026-08-03
00190776408671Millennium85-220140482026-08-03
00190776408688Millennium85-780029742026-08-03
00190776408695Millennium85-600048132026-08-03
00190776408718Millennium85-250056502026-08-03
00190776408725Millennium85-600098002026-08-03
00190776408732Millennium85-160225992026-08-03
00190776408749Millennium85-710033452026-08-03
00190776408756Millennium85-620453222026-08-03
00190776408763Millennium85-120145262026-08-03
00190776408817Millennium85-310P447392026-08-03
00190776408824Millennium85-710026302026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886907179U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-04-25
04719886907186U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-04-25
04719886907193U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-04-25
04719886905526U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-03-05
04026575290017Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575290031Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575290055Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575290062Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292080Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292097Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292103Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292127Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575407576Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575312832LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312856LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312870LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312894LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312917LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312931LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312955LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312979LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312993LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575313013LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575301935Link Embrace Shoulder System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-15
04026575217762SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-15
04026575301959Link Embrace Shoulder System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-15
04719886890440U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2022-10-14
00840277124241Innomed, Inc.INNOMED, INC.HWP2022-08-08
00887868494406Vanguard® Microplasty®Biomet Orthopedics, LLCHWP2022-06-22
00887868497377Vanguard®Biomet Orthopedics, LLCHWP2022-04-23