VISION FIXATION SYSTEM 14186

GUDID 00880304529854

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00880304529854
• NIH Device Record Key: 7f6fbb9f-58cf-4309-bb6f-bbd8d728b828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISION FIXATION SYSTEM
• Version Model Number: 14186
• Catalog Number: 14186
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304529854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011711

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

Moist Heat or Steam Sterilization

[00880304529854]

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: 2015-10-24

On-Brand Devices [VISION FIXATION SYSTEM]

• 00880304532205: 21252
• 00880304529854: 14186
• 00880304509658: 14069
• 00880304505087: 14290
• 00880304501294: 14080
• 00880304501270: 14255
• 00880304496361: 14285
• 00880304487734: 14330
• 00880304486553: 14280
• 00880304486478: 14240
• 00880304485174: 14250
• 00888480188742: 14382
• 00888480188735: 14380
• 00888480188698: 14365
• 00888480188483: 14230
• 00888480188063: 14075
• 00888480188049: 14070
• 00888480188018: 14065
• 00888480187769: 14022
• 00887868090226: 14105
• 00887868090028: 14030
• 00888480221463: 21258
• 00888480221449: 21256
• 00888480221418: 21250