2.4MM STERNALOCK (TM) SYSTEM 75-6412

GUDID 00841036078850

BIOMET MICROFIXATION, INC

Sternal fixation device

• Primary Device ID: 00841036078850
• NIH Device Record Key: 63b286d4-f322-4fd3-9bfe-9ece55363bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4MM STERNALOCK (TM) SYSTEM
• Version Model Number: 75-6412
• Catalog Number: 75-6412
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036078850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033740

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841036078850]

Moist Heat or Steam Sterilization

[00841036078850]

Moist Heat or Steam Sterilization

[00841036078850]

Moist Heat or Steam Sterilization

[00841036078850]

Moist Heat or Steam Sterilization

[00841036078850]

Moist Heat or Steam Sterilization

[00841036078850]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

On-Brand Devices [2.4MM STERNALOCK (TM) SYSTEM]

• 00841036079987: 75-6408
• 00841036078850: 75-6412
• 00841036078812: 75-6410
• 00841036075606: 71-6410
• 00841036075590: 71-6412
• 00841036074814: 71-6408
• 00841036073756: 75-2716
• 00841036073732: 75-2712
• 00841036073695: 75-2710
• 00841036073664: 75-2714
• 00841036072544: 71-2643
• 00841036072186: 75-2708
• 00841036071769: 71-2716
• 00841036071752: 71-2710
• 00841036071745: 71-2712
• 00841036071738: 71-2714
• 00841036069872: 71-2708