VISION PIN-TO-BAR FIXATION SYSTEM 14355

GUDID 00880304491120

Biomet Orthopedics, LLC

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

• Primary Device ID: 00880304491120
• NIH Device Record Key: 10d5e491-a8e6-4233-89ce-70918d0b304c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISION PIN-TO-BAR FIXATION SYSTEM
• Version Model Number: 14355
• Catalog Number: 14355
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304491120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081244
• Premarket Notification: K993886

FDA Product Code

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

Sterilization

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

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

Moist Heat or Steam Sterilization

[00880304491120]

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 PIN-TO-BAR FIXATION SYSTEM]

• 00880304529236: 21285
• 00880304529229: 21280
• 00880304529212: 21290
• 00880304505070: 14045
• 00880304501140: 14060
• 00880304498150: 14-400070
• 00880304495210: 14-400065
• 00880304492950: 14600
• 00880304492684: 14350
• 00880304491229: 14605
• 00880304491120: 14355
• 00880304488281: 14055
• 00880304486515: 14360
• 00880304485365: 14090
• 00888480188407: 14155
• 00888480188391: 14150
• 00888480188360: 14145
• 00888480188353: 14140
• 00888480188322: 14135
• 00888480188315: 14130
• 00888480188292: 14120
• 00888480188100: 14085
• 00888480187745: 14010
• 00887868098390: 14005
• 00887868090233: 14110
• 00887868090219: 14100
• 00887868090004: 14025