Comprehensive Reverse Shoulder - Mini Baseplate SSI003434

GUDID 00880304848351

Biomet Orthopedics, LLC

Glenoid orthopaedic reamer

• Primary Device ID: 00880304848351
• NIH Device Record Key: 17ef9dd6-88d7-438c-8f3b-7c72f94e4d34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive Reverse Shoulder - Mini Baseplate
• Version Model Number: SSI003434
• Catalog Number: SSI003434
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304848351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120121

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[00880304848351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-27

On-Brand Devices [Comprehensive Reverse Shoulder - Mini Baseplate]

• 00880304848351: SSI003434
• 00880304848238: SSI003354