Hybrid® Glenoid Instrumentation 406194

GUDID 00887868505096

Biomet Orthopedics, LLC

Shoulder glenoid fossa prosthesis trial

• Primary Device ID: 00887868505096
• NIH Device Record Key: 69a111ef-ca93-4c37-9faf-97abd14d47d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybrid® Glenoid Instrumentation
• Version Model Number: 406194
• Catalog Number: 406194
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868505096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• MBF: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Sterilization

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

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

[00887868505096]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-23

On-Brand Devices [Hybrid® Glenoid Instrumentation]

• 00887868505027: 406165
• 00887868505010: 406163
• 00887868505003: 406161
• 00887868505096: 406194
• 00887868505089: 406193
• 00887868505072: 406192
• 00887868505058: 406174
• 00887868505041: 406173
• 00887868505034: 406172