Zimmer NexGen® Complete Knee Solution 82-0156-525-14

GUDID 00889024473263

Zimmer, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00889024473263
• NIH Device Record Key: b124a1c4-93ef-45fe-ab09-1598bde5b458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer NexGen® Complete Knee Solution
• Version Model Number: 82-0156-525-14
• Catalog Number: 82-0156-525-14
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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

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	00889024473263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072160

FDA Product Code

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

Sterilization

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

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

Moist Heat or Steam Sterilization

[00889024473263]

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: 2016-10-21

On-Brand Devices [Zimmer NexGen® Complete Knee Solution]

• 00889024473324: 82-0156-525-20
• 00889024473317: 82-0156-525-19
• 00889024473300: 82-0156-525-18
• 00889024473294: 82-0156-525-17
• 00889024473287: 82-0156-525-16
• 00889024473270: 82-0156-525-15
• 00889024473263: 82-0156-525-14
• 00889024473256: 82-0156-525-13
• 00889024473249: 82-0156-525-12