STERNALOCK® SYSTEM SP-2365

GUDID 00841036135645

BIOMET MICROFIXATION, INC

Sternal fixation device

• Primary Device ID: 00841036135645
• NIH Device Record Key: 7460694f-aa99-46f7-8305-9ba8317acdfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERNALOCK® SYSTEM
• Version Model Number: SP-2365
• Catalog Number: SP-2365
• 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	00841036135645 [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

[00841036135645]

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® SYSTEM]

• 00841036147341: SP-2725
• 00841036138462: SP-2441
• 00841036138424: SP-2374
• 00841036135997: 71-2634
• 00841036135645: SP-2365
• 00841036123444: 71-2636
• 00841036123109: 71-2632