Zimmer Persona Knee System 82-0153-187-05

GUDID 00880304848597

Biomet Orthopedics, LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00880304848597
• NIH Device Record Key: a20a3bb2-6e5a-414c-84a3-640f3a0cc15d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer Persona Knee System
• Version Model Number: 82-0153-187-05
• Catalog Number: 82-0153-187-05
• 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: false
• Serial Number: true
• 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	00880304848597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113369

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

[00880304848597]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-09-30

On-Brand Devices [Zimmer Persona Knee System]

• 00880304848764: 82-0153-185-32
• 00880304848757: 82-0153-185-31
• 00880304848740: 82-0153-185-30
• 00880304848733: 82-0153-185-29
• 00880304848726: 82-0153-185-28
• 00880304848719: 82-0153-185-27
• 00880304848702: 82-0153-185-26
• 00880304848696: 82-0153-185-25
• 00880304848689: 82-0153-185-24
• 00880304848672: 82-0153-185-23
• 00880304848665: 82-0153-187-12
• 00880304848658: 82-0153-187-11
• 00880304848641: 82-0153-187-10
• 00880304848634: 82-0153-187-09
• 00880304848627: 82-0153-187-08
• 00880304848610: 82-0153-187-07
• 00880304848603: 82-0153-187-06
• 00880304848597: 82-0153-187-05
• 00880304848580: 82-0153-187-04
• 00880304848573: 82-0153-187-03
• 00880304848566: 82-0153-187-02
• 00880304848559: 82-0153-187-01