VANGUARD CR UNIVERSAL PROVISIONAL 32-483780

GUDID 00880304436459

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304436459
• NIH Device Record Key: cb261809-5dc4-45aa-9a24-a96c6389b540
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD CR UNIVERSAL PROVISIONAL
• Version Model Number: 32-483780
• Catalog Number: 32-483780
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304436459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

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

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

Moist Heat or Steam Sterilization

[00880304436459]

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 CR UNIVERSAL PROVISIONAL]

• 00880304531031: 32-483772
• 00880304530812: 32-483732
• 00880304530805: 32-483774
• 00880304530133: 32-483734
• 00880304455917: 32-483766
• 00880304455900: 32-483764
• 00880304455894: 32-483762
• 00880304454712: 32-483726
• 00880304454705: 32-483724
• 00880304453562: 32-483720
• 00880304453555: 32-483760
• 00880304452602: 32-483728
• 00880304452596: 32-483768
• 00880304446564: 32-483722
• 00880304436497: 32-483784
• 00880304436480: 32-483706
• 00880304436473: 32-483700
• 00880304436466: 32-483702
• 00880304436459: 32-483780
• 00880304436442: 32-483786
• 00880304436435: 32-483788
• 00880304436428: 32-483782
• 00880304436411: 32-483708
• 00880304436404: 32-483704