Vanguard® 360 OsseoTi® Instrument 32-360003

GUDID 00887868570544

Biomet Orthopedics, LLC

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• Primary Device ID: 00887868570544
• NIH Device Record Key: d4aa7126-69bb-4779-9fe4-8040d2d56542
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vanguard® 360 OsseoTi® Instrument
• Version Model Number: 32-360003
• Catalog Number: 32-360003
• 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

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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868570544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140883

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

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

[00887868570544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

On-Brand Devices [Vanguard® 360 OsseoTi® Instrument]

• 00887868570582: 32-360008
• 00887868570575: 32-360007
• 00887868570568: 32-360006
• 00887868570551: 32-360005
• 00887868570544: 32-360003
• 00887868570537: 32-360002
• 00887868570520: 32-360001
• 00887868570513: 32-360000