VANGUARD GLOBAL INSTRUMENTS 110026753

GUDID 00880304710016

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304710016
• NIH Device Record Key: a5f27e9b-9ab6-40ab-96b9-4921ab9914d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD GLOBAL INSTRUMENTS
• Version Model Number: 110026753
• Catalog Number: 110026753
• 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: 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(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
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304710016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

[00880304710016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-04-07

On-Brand Devices [VANGUARD GLOBAL INSTRUMENTS]

• 00880304710214: 110026773
• 00880304710207: 110026772
• 00880304710191: 110026771
• 00880304710177: 110026769
• 00880304710160: 110026768
• 00880304710153: 110026767
• 00880304710139: 110026765
• 00880304710122: 110026764
• 00880304710115: 110026763
• 00880304710030: 110026755
• 00880304710023: 110026754
• 00880304710016: 110026753
• 00880304710009: 110026752
• 00880304709997: 110026751
• 00880304709980: 110026750
• 00880304709973: 110026749
• 00880304709966: 110026748
• 00880304709959: 110026747
• 00880304709942: 110026746
• 00880304709935: 110026745
• 00880304697232: 110026744
• 00880304697225: 110026743
• 00880304697218: 110026742
• 00880304697201: 110026741
• 00880304697195: 110026740
• 00880304697188: 110026739
• 00880304697171: 110026738
• 00880304697102: 110026731
• 00880304697096: 110026730
• 00880304697089: 110026729
• 00880304697072: 110026728
• 00880304697065: 110026727
• 00880304697058: 110026726
• 00880304697041: 110026725
• 00880304697034: 110026724
• 00880304697027: 110026723
• 00880304696952: 110026716
• 00880304696945: 110026715
• 00880304696938: 110026714
• 00880304696921: 110026713
• 00880304696914: 110026712
• 00880304696907: 110026711
• 00880304696891: 110026710
• 00880304696884: 110026709
• 00880304696877: 110026708
• 00880304696259: 110026415
• 00880304696242: 110026414
• 00880304696235: 110026411
• 00880304696228: 110026410
• 00880304696211: 110026407