2.0/2.4MM FRACTURE SYSTEM 24-1068

GUDID 00841036036010

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: 00841036036010
• NIH Device Record Key: e69a9d17-d65a-48c0-aac7-73e639c7f11b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0/2.4MM FRACTURE SYSTEM
• Version Model Number: 24-1068
• Catalog Number: 24-1068
• 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	00841036036010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001238

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

Moist Heat or Steam Sterilization

[00841036036010]

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 [2.0/2.4MM FRACTURE SYSTEM]

• 00841036036225: 24-1186
• 00841036070373: 24-1082
• 00841036036256: 2.4MM X-LOCK CROSS-DRIVE SHORT BLADE
• 00841036036072: PLATE HOLDING FORCEPS
• 00841036036027: 24-1080
• 00841036036010: 24-1068
• 00841036036003: 24-1066
• 00841036035990: 24-1064
• 00841036035983: 24-1060
• 00841036035969: 24-1056
• 00841036035952: 24-1054
• 00841036035945: 24-1052
• 00841036035938: 24-1050