COMP REVRS 1 PC RESECT GUIDE ASSY SSI005290

GUDID 00889024581098

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00889024581098
• NIH Device Record Key: ff639237-0db1-4215-b10b-a30b2f7126e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMP REVRS 1 PC RESECT GUIDE ASSY
• Version Model Number: SSI005290
• Catalog Number: SSI005290
• 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	00889024581098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080642

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

[00889024581098]

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

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11