Augmented BP Rmr Gd Inserter SSI005400

GUDID 00889024583047

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00889024583047
• NIH Device Record Key: 528a7ce1-5dbf-40d8-8e0a-0d2f725ea70b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Augmented BP Rmr Gd Inserter
• Version Model Number: SSI005400
• Catalog Number: SSI005400
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024583047 [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

[00889024583047]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

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