TOTAL MANDIBULAR SYSTEM 24-4544

GUDID 00841036063566

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: 00841036063566
• NIH Device Record Key: 60a36e2e-4a05-4267-a213-93bd611f54d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTAL MANDIBULAR SYSTEM
• Version Model Number: 24-4544
• Catalog Number: 24-4544
• 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
• 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
• 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	00841036063566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113512

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

Moist Heat or Steam Sterilization

[00841036063566]

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 [TOTAL MANDIBULAR SYSTEM]

• 00841036066826: 24-1136
• 00841036062774: 24-1135
• 00841036062682: 24-1130
• 00841036062552: 24-1131
• 00841036061432: 24-1138
• 00841036065089: 20-1300
• 00841036063573: 24-4545
• 00841036063566: 24-4544
• 00841036063467: 24-2550
• 00841036063238: 24-1302
• 00841036062842: 24-2556
• 00841036062415: 24-2400
• 00841036061852: 24-2555
• 00841036061142: 24-1308
• 00841036060824: 24-2115
• 00841036060817: 24-1306
• 00841036059279: 24-2050