Modular Hybrid Glenoid SSI000927

GUDID 00887868232015

Biomet Orthopedics, LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00887868232015
• NIH Device Record Key: d67570ed-5fbd-4957-9b7f-a352e1d36d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Hybrid Glenoid
• Version Model Number: SSI000927
• Catalog Number: SSI000927
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868232015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

[00887868232015]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-26

On-Brand Devices [Modular Hybrid Glenoid]

• 00887868242601: 406152
• 00887868242595: 406151
• 00887868242588: 406150
• 00887868232022: SSI000928
• 00887868232015: SSI000927
• 00887868232008: SSI000926
• 00887868231995: SSI000792
• 00887868231988: SSI000791
• 00887868231971: SSI000790
• 00887868229299: SSI002589
• 00887868229282: SSI002588
• 00887868229275: SSI002563
• 00887868229268: SSI002562
• 00887868227172: SSI001146
• 00887868227165: SSI001145
• 00887868227158: SSI001144