MAK OSS™ CP461011

GUDID 00887868519420

Biomet Orthopedics, LLC

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• Primary Device ID: 00887868519420
• NIH Device Record Key: b213977e-cb6d-4ef5-85e8-84ed0db01ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAK OSS™
• Version Model Number: CP461011
• Catalog Number: CP461011
• 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
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868519420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131393

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

[00887868519420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-23

On-Brand Devices [MAK OSS™]

• 00887868519437: CP461012
• 00887868519420: CP461011