STERNALOCK 360 SYSTEM 74-0003

GUDID 00888233026598

BIOMET MICROFIXATION, INC

Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device

• Primary Device ID: 00888233026598
• NIH Device Record Key: a95bd37d-7d2f-469f-97e5-ff69430d3b92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERNALOCK 360 SYSTEM
• Version Model Number: 74-0003
• Catalog Number: 74-0003
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888233026598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151019

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-08
• Device Publish Date: 2020-06-30

On-Brand Devices [STERNALOCK 360 SYSTEM]

• 00841036192136: 74-1192
• 00841036275273: 74-1193
• 00841036275266: 74-1192
• 00841036202484: 74-1195
• 00841036192143: 74-1193
• 00841036190668: 74-0004
• 00841036190231: 74-0016
• 00841036190224: 74-0014
• 00841036190217: 74-0012
• 00841036190200: 74-0010
• 00841036190026: 74-0002
• 00841036190019: 74-0003
• 00888233026604: 74-0004
• 00888233026598: 74-0003
• 00888233026581: 74-0002