STERNALOCK(TM) SYSTEM 5/PK 75-6414

GUDID 00841036123031

BIOMET MICROFIXATION, INC

Sternal fixation device

• Primary Device ID: 00841036123031
• NIH Device Record Key: af0ba368-9937-413a-a457-dd65d63c915d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERNALOCK(TM) SYSTEM 5/PK
• Version Model Number: 75-6414
• Catalog Number: 75-6414
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036123031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063506

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00841036123031]

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 [STERNALOCK(TM) SYSTEM 5/PK]

• 00841036123031: 75-6414
• 00841036122867: 75-6416