VANGUARD(TM) PROVISIONAL 32-489106

GUDID 00880304444713

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304444713
• NIH Device Record Key: d4cdaf6c-2397-48ae-b0b8-58c75415c958
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD(TM) PROVISIONAL
• Version Model Number: 32-489106
• Catalog Number: 32-489106
• 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: true
• 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	00880304444713 [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

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

Moist Heat or Steam Sterilization

[00880304444713]

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: 2016-10-25

On-Brand Devices [VANGUARD(TM) PROVISIONAL]

• 00880304611726: 32-483472
• 00880304611719: 32-483454
• 00880304611702: 32-483408
• 00880304611696: 32-483406
• 00880304611689: 32-483404
• 00880304611672: 32-483402
• 00880304611665: 32-483400
• 00880304543317: 32-483466
• 00880304543300: 32-483448
• 00880304543294: 32-483446
• 00880304543287: 32-483442
• 00880304543270: 32-483426
• 00880304543263: 32-483468
• 00880304543256: 32-483444
• 00880304543249: 32-483464
• 00880304543225: 32-483424
• 00880304543218: 32-483428
• 00880304531819: 32-483754
• 00880304529304: 32-483752
• 00880304522312: 32-483420
• 00880304522190: 32-483460
• 00880304508897: 32-489114
• 00880304508880: 32-489094
• 00880304508873: 32-489052
• 00880304508866: 32-489054
• 00880304508859: 32-489032
• 00880304508842: 32-489092
• 00880304508835: 32-489074
• 00880304508828: 32-489072
• 00880304508811: 32-489112
• 00880304508804: 32-489034
• 00880304506299: 32-483440
• 00880304481008: 32-483462
• 00880304457270: 32-483422
• 00880304454699: 32-483742
• 00880304454682: 32-483744
• 00880304452503: 32-483746
• 00880304449107: 32-483434
• 00880304446694: 32-483740
• 00880304444744: 32-489028
• 00880304444713: 32-489106
• 00880304444614: 32-489064
• 00880304444577: 32-489084
• 00880304444560: 32-489086
• 00880304444553: 32-489120
• 00880304444539: 32-489102
• 00880304444508: 32-489046
• 00880304440012: 32-483748
• 05019279453535: 32-489134
• 05019279453511: 32-489132