1.0MM SYSTEM SP-2048

GUDID 00841036282677

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: 00841036282677
• NIH Device Record Key: 6301d37a-12d0-4ff7-bcac-51da66e8f599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.0MM SYSTEM
• Version Model Number: SP-2048
• Catalog Number: SP-2048
• 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	00841036282677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

[00841036282677]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-06
• Device Publish Date: 2020-03-27

On-Brand Devices [1.0MM SYSTEM]

• 00841036282677: SP-2048
• 00841036282660: SP-2047
• 00841036124021: SP-2048
• 00841036124014: SP-2047
• 00841036014346: 01-7460