VANGUARD 32-489148

GUDID 00880304533943

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304533943
• NIH Device Record Key: 45b9e8f8-1e2b-49d7-be93-4b516da65339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD
• Version Model Number: 32-489148
• Catalog Number: 32-489148
• 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
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304533943 [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

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

Moist Heat or Steam Sterilization

[00880304533943]

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: 2016-09-21

On-Brand Devices [VANGUARD]

• 00880304856318: SSI002132
• 00880304856301: SSI002130
• 00880304856295: SSI002128
• 00880304849150: SSI002495
• 00880304849143: SSI002494
• 00880304849136: SSI002493
• 00880304849129: SSI002492
• 00880304849112: SSI002491
• 00880304849105: SSI002490
• 00880304849099: SSI002489
• 00880304849082: SSI002488
• 00880304849075: SSI002487
• 00880304849068: SSI002486
• 00880304849051: SSI002485
• 00880304849044: SSI002484
• 00880304849037: SSI002483
• 00880304849020: SSI002482
• 00880304849013: SSI002481
• 00880304716308: 32-423131
• 00880304533974: 32-489144
• 00880304533967: 32-489146
• 00880304533950: 32-489140
• 00880304533943: 32-489148
• 00880304533936: 32-489142
• 00880304530744: 596702
• 00880304530607: 596701
• 00880304523791: 32-486001
• 00880304523173: 32-360900
• 00880304516359: 32-360504
• 00880304516342: 32-360502
• 00880304516335: 32-360500
• 00880304516144: 32-360506
• 00880304516137: 32-360508
• 00880304515888: 32-360514
• 00880304515871: 32-360510
• 00880304515765: 32-360512
• 00880304501867: 32-360108
• 00880304501751: 32-360101
• 00880304501737: 32-360102
• 00880304496439: 32-360089
• 00880304496194: 32-488051
• 00880304496118: 32-360081
• 00880304495821: 32-488055
• 00880304495586: 32-488057
• 00880304495555: 32-488053
• 00880304472648: 596037
• 00880304446014: 32-488517
• 00880304446007: 32-488515
• 00880304445994: 32-488516
• 00880304445598: 32-487214