NexGen Knee System 82-0152-982-16

GUDID 00889024472938

Zimmer, Inc.

Knee femur prosthesis trial

• Primary Device ID: 00889024472938
• NIH Device Record Key: 401e133c-6ea0-44b9-9cec-b6538ec1dfc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen Knee System
• Version Model Number: 82-0152-982-16
• Catalog Number: 82-0152-982-16
• 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	00889024472938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960279

FDA Product Code

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

Sterilization

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

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

Moist Heat or Steam Sterilization

[00889024472938]

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: 2016-12-22

On-Brand Devices [NexGen Knee System]

• 00889024473010: 82-0152-982-27
• 00889024473003: 82-0152-982-26
• 00889024472990: 82-0152-982-25
• 00889024472983: 82-0152-982-24
• 00889024472976: 82-0152-982-23
• 00889024472969: 82-0152-982-22
• 00889024472952: 82-0152-982-21
• 00889024472945: 82-0152-982-17
• 00889024472938: 82-0152-982-16
• 00889024472921: 82-0152-982-15
• 00889024472914: 82-0152-982-14
• 00889024472907: 82-0152-982-13
• 00889024472891: 82-0152-982-12
• 00889024472884: 82-0152-982-11
• 00889024472877: 82-0152-907-30