VANGUARD(TM) MICROPLASTY(R) 32-485504

GUDID 00880304349735

Biomet Orthopedics, LLC

Surgical implant template, reusable

• Primary Device ID: 00880304349735
• NIH Device Record Key: 39aad4e4-da15-48af-9577-8d4294e30f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD(TM) MICROPLASTY(R)
• Version Model Number: 32-485504
• Catalog Number: 32-485504
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304349735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142933

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

[00880304349735]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [VANGUARD(TM) MICROPLASTY(R)]

• 00880304612341: 32-485012
• 00880304429628: 32-485557
• 00880304429611: 32-485556
• 00880304429604: 32-485555
• 00880304349940: 32-486205
• 00880304349834: 32-485550
• 00880304349827: 32-485525
• 00880304349810: 32-485521
• 00880304349803: 32-485520
• 00880304349797: 32-485511
• 00880304349780: 32-485510
• 00880304349773: 32-485508
• 00880304349766: 32-485507
• 00880304349759: 32-485506
• 00880304349742: 32-485505
• 00880304349735: 32-485504
• 00880304349728: 32-485503
• 00880304349711: 32-485502
• 00880304349704: 32-485501
• 00880304349698: 32-485500
• 00880304349681: 32-485108
• 00880304349667: 32-485106
• 00880304349650: 32-485105
• 00880304349643: 32-485104
• 00880304349636: 32-485103
• 00880304349629: 32-485102
• 00880304349612: 32-485101
• 00880304349605: 32-485100
• 00880304349599: 32-485057
• 00880304349582: 32-485056
• 00880304349568: 32-485054
• 00880304349551: 32-485053
• 00880304428546: 32-485559
• 00880304428539: 32-485558
• 00880304349674: 32-485107
• 00880304349520: 32-485050
• 00880304349452: 32-485003
• 05019279439256: 32-485002