1.5MM SYSTEM - CRANIOCURVE (TM) MESH 01-9523

GUDID 00841036155650

BIOMET MICROFIXATION, INC

Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable

• Primary Device ID: 00841036155650
• NIH Device Record Key: 32ac38cd-e909-4aff-9690-8842c1ec635e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5MM SYSTEM - CRANIOCURVE (TM) MESH
• Version Model Number: 01-9523
• Catalog Number: 01-9523
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036155650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121624

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

Moist Heat or Steam Sterilization

[00841036155650]

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 [1.5MM SYSTEM - CRANIOCURVE (TM) MESH]

• 00841036201289: SP-3253
• 00841036193881: SP-3235
• 00841036193874: SP-3234
• 00841036193867: SP-3233
• 00841036193850: SP-3232
• 00841036193843: SP-3231
• 00841036155650: 01-9523
• 00841036155643: 01-9524
• 00841036153663: 01-9522
• 00841036153656: 01-9521
• 00841036153649: 01-9520