NEURO SYSTEM 19-5006

GUDID 00841036187644

BIOMET MICROFIXATION, INC

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00841036187644
• NIH Device Record Key: 9b3e30c6-a65b-45a8-bb89-a1a090c2d849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEURO SYSTEM
• Version Model Number: 19-5006
• Catalog Number: 19-5006
• 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: false
• 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
• 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	00841036187644 [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

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

[00841036187644]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2015-10-11

On-Brand Devices [NEURO SYSTEM]

• 00841036197742: 15-5010
• 00841036188054: 15-5003
• 00841036187644: 19-5006
• 00841036187637: 15-5006
• 00841036187422: 15-5000
• 00841036187415: 19-5000
• 00841036182571: 19-5002
• 00841036182564: 19-5001
• 00841036182557: 17-5000
• 00841036182540: 17-5006
• 00841036182533: 15-5002
• 00841036182526: 15-5001
• 00841036123888: 19-1000
• 00888233007320: 19-5006
• 00888233007306: 19-5002
• 00888233007269: 19-5001
• 00888233007245: 19-5000
• 00888233007207: 17-5006
• 00888233007184: 17-5000
• 00888233006934: 15-5010
• 00888233006897: 15-5006
• 00888233006828: 15-5003
• 00888233006804: 15-5002
• 00888233006767: 15-5001
• 00888233006743: 15-5000