VANGUARD INSTRUMENT 32-360528

GUDID 00880304515857

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304515857
• NIH Device Record Key: 997e4c0c-1c36-416a-bb14-eeb8a1f41634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD INSTRUMENT
• Version Model Number: 32-360528
• Catalog Number: 32-360528
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304515857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093293

FDA Product Code

• MBV: Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer

Sterilization

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

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

Moist Heat or Steam Sterilization

[00880304515857]

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 INSTRUMENT]

• 00880304522817: 32-486131
• 00880304516274: 32-360522
• 00880304516267: 32-360594
• 00880304516250: 32-360592
• 00880304516120: 32-360542
• 00880304516113: 32-360546
• 00880304516106: 32-360540
• 00880304516090: 32-360526
• 00880304516038: 32-360586
• 00880304516021: 32-360580
• 00880304516014: 32-360550
• 00880304516007: 32-360548
• 00880304515994: 32-360560
• 00880304515987: 32-360530
• 00880304515864: 32-360544
• 00880304515857: 32-360528
• 00880304515840: 32-360520
• 00880304515833: 32-360570
• 00880304515826: 32-360568
• 00880304515819: 32-360588
• 00880304515802: 32-360584
• 00880304515796: 32-360590
• 00880304515789: 32-360552
• 00880304515772: 32-360574
• 00880304515758: 32-360532
• 00880304515741: 32-360524
• 00880304515734: 32-360572
• 00880304515727: 32-360534
• 00880304515710: 32-360554
• 00880304515703: 32-360562
• 00880304515697: 32-360566
• 00880304515680: 32-360582
• 00880304515666: 32-360564
• 00880304501942: 32-486254
• 00880304496071: 32-360299
• 00880304349995: 32-486255