EXTERNAL DISTRACTION SYSTEM 99-5926

GUDID 00841036066796

BIOMET MICROFIXATION, INC

Orthopaedic bone wire

• Primary Device ID: 00841036066796
• NIH Device Record Key: adbddd56-c079-42c8-9cbf-26266ce3a5a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTERNAL DISTRACTION SYSTEM
• Version Model Number: 99-5926
• Catalog Number: 99-5926
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036066796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831005

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00841036066796]

Moist Heat or Steam Sterilization

[00841036066796]

Moist Heat or Steam Sterilization

[00841036066796]

Moist Heat or Steam Sterilization

[00841036066796]

Moist Heat or Steam Sterilization

[00841036066796]

Moist Heat or Steam Sterilization

[00841036066796]

Moist Heat or Steam Sterilization

[00841036066796]

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: 2015-11-25

On-Brand Devices [EXTERNAL DISTRACTION SYSTEM]

• 00841036057435: 99-3582
• 00841036057428: 99-3581
• 00841036057411: 99-3575
• 00841036057404: 99-3572
• 00841036057398: 99-3570
• 00841036010942: 01-3587
• 00841036010935: 01-3586
• 00841036010928: 01-3585
• 00841036010911: 01-3584
• 00841036010904: 01-3580
• 00841036010850: 01-3552
• 00841036010843: 01-3551
• 00841036072650: 99-5924
• 00841036070885: 99-5918
• 00841036066796: 99-5926
• 00841036011338: 01-5926
• 00841036011321: 01-5924
• 00841036011314: 01-5918