1.5MM NEURO SYSTEM 15-5007

GUDID 00841036190590

BIOMET MICROFIXATION, INC

Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack

• Primary Device ID: 00841036190590
• NIH Device Record Key: 3edeaef1-5a99-4c48-9e59-6108fd6e5ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5MM NEURO SYSTEM
• Version Model Number: 15-5007
• Catalog Number: 15-5007
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036190590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121624

FDA Product Code

• HBW: FASTENER, PLATE, CRANIOPLASTY

Sterilization

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

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

Moist Heat or Steam Sterilization

[00841036190590]

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: 2016-03-23

On-Brand Devices [1.5MM NEURO SYSTEM]

• 00841036190590: 15-5007
• 00841036190583: 15-5004
• 00888233006873: 15-5004