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

GUDID 00841036155650

BIOMET MICROFIXATION, INC

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