2.4MM STERNALOCK (TM) (1 PC SCREW) 71-2648

GUDID 00841036067045

BIOMET MICROFIXATION, INC

Sternal fixation device

• Primary Device ID: 00841036067045
• NIH Device Record Key: 4b9f819a-6584-4f7f-9ad4-01a698ff5093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4MM STERNALOCK (TM) (1 PC SCREW)
• Version Model Number: 71-2648
• Catalog Number: 71-2648
• 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	00841036067045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011076

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00841036067045]

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) (1 PC SCREW)]

• 00841036068752: 71-2622
• 00841036067809: 71-2625
• 00841036067045: 71-2648