HYBRID(TM) GLENOID INSTRUMENTATION 406174

GUDID 00880304456419

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00880304456419
• NIH Device Record Key: ceef0b8e-421c-46e9-a313-3502888c8cea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYBRID(TM) GLENOID INSTRUMENTATION
• Version Model Number: 406174
• Catalog Number: 406174
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304456419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• HWT: TEMPLATE
• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

[00880304456419]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-07-28

On-Brand Devices [HYBRID(TM) GLENOID INSTRUMENTATION]

• 00880304456549: 406192
• 00880304456525: 406193
• 00880304456495: 406194
• 00880304456433: 406172
• 00880304456426: 406173
• 00880304456419: 406174