FDA.reportPublic FDA data

Millennium

Primary DI
00190776183677
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-02211
Device description
CUSTOM PIN PUNCH .
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
HWPPUNCH, FEMORAL NECK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWPPunch, Femoral NeckOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776183677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776183677001907761836771907761836770190776183677

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

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
00190776379155MillenniumAvalign Technologies, Inc.HWP2023-10-16
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