Vanguard® 360 Instrument OsseoTi® 32-360080

GUDID 00887868562297

Biomet Orthopedics, LLC

Orthopaedic implant impactor, reusable

• Primary Device ID: 00887868562297
• NIH Device Record Key: e94732d0-db29-4a00-ac2b-474ade5e82ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vanguard® 360 Instrument OsseoTi®
• Version Model Number: 32-360080
• Catalog Number: 32-360080
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868562297 [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

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

[00887868562297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-13
• Device Publish Date: 2023-07-05

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

• 00887868562297: 32-360080
• 00887868571565: 32-360035
• 00887868571558: 32-360034
• 00887868571541: 32-360033
• 00887868571534: 32-360028
• 00887868571527: 32-360027
• 00887868571510: 32-360026
• 00887868571503: 32-360025