PRELUDE PF TRIAL REMOVER 110004169

GUDID 00880304567252

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00880304567252
• NIH Device Record Key: acc50642-3075-40a9-abfd-2c3c97b756bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRELUDE PF TRIAL REMOVER
• Version Model Number: 110004169
• Catalog Number: 110004169
• 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: true
• 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	00880304567252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143543

FDA Product Code

• KRR: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00880304567252]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-28

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