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
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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
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
00887868493188Vanguard® Microplasty® InstrumentsBiomet Orthopedics, LLCHWP2022-03-19