MODIFIED MINI TRAY +5 6MM OFFSET SSI005791

GUDID 00889024585379

Biomet Orthopedics, LLC

Reverse shoulder cup prosthesis trial

• Primary Device ID: 00889024585379
• NIH Device Record Key: 96adadfc-ea67-4f2f-9c6f-a8ba4bad8ca1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODIFIED MINI TRAY +5 6MM OFFSET
• Version Model Number: SSI005791
• Catalog Number: SSI005791
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024585379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181611

FDA Product Code

• PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-21
• Device Publish Date: 2020-01-13

Devices Manufactured by Biomet Orthopedics, LLC

• 00889024664739 - JuggerKnot Short Rigid Reusable Guide: 2024-07-29
• 00889024674288 - HAMMR™: 2024-07-03
• 00887868555732 - Patient Specific Planning Solution™: 2024-06-25
• 00880304658462 - Compress®: 2024-05-24
• 00889024663794 - HAMMR™: 2024-05-17
• 00889024663800 - HAMMR™: 2024-05-17
• 00889024663817 - HAMMR™: 2024-05-17
• 00889024663824 - HAMMR™: 2024-05-17