OSS TOTAL FEMORAL COUPLER TRIAL 110018681

GUDID 00880304678668

Biomet Orthopedics, LLC

Knee femur prosthesis trial Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable

• Primary Device ID: 00880304678668
• NIH Device Record Key: 297e3cf5-33d7-4ced-b851-3e7c0733c8f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS TOTAL FEMORAL COUPLER TRIAL
• Version Model Number: 110018681
• Catalog Number: 110018681
• 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
• 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
• 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 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	00880304678668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

[00880304678668]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-27

On-Brand Devices [OSS TOTAL FEMORAL COUPLER TRIAL]

• 00880304678668: 110018681
• 00880304678651: 110018680