STERNALOCK 360 SYSTEM 74-1195

GUDID 00841036202484

BIOMET MICROFIXATION, INC

Manual orthopaedic bender, reusable

• Primary Device ID: 00841036202484
• NIH Device Record Key: e76b3ec8-2d60-4d3e-ae57-8a3b0ca4ba05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERNALOCK 360 SYSTEM
• Version Model Number: 74-1195
• Catalog Number: 74-1195
• 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: false
• 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	00841036202484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151019

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00841036202484]

Moist Heat or Steam Sterilization

[00841036202484]

Moist Heat or Steam Sterilization

[00841036202484]

Moist Heat or Steam Sterilization

[00841036202484]

Moist Heat or Steam Sterilization

[00841036202484]

Moist Heat or Steam Sterilization

[00841036202484]

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: 2015-11-17

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