NexGen Complete Knee Solution (CR-Flex) 82-0153-002-09

GUDID 00889024473119

Zimmer, Inc.

Knee femur prosthesis trial

• Primary Device ID: 00889024473119
• NIH Device Record Key: dfd4e032-24e0-4c5c-a282-45d76316272d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen Complete Knee Solution (CR-Flex)
• Version Model Number: 82-0153-002-09
• Catalog Number: 82-0153-002-09
• 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: true
• 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	00889024473119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023211

FDA Product Code

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

Sterilization

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

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

Moist Heat or Steam Sterilization

[00889024473119]

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: 2017-01-30

On-Brand Devices [NexGen Complete Knee Solution (CR-Flex)]

• 00889024473119: 82-0153-002-09
• 00889024473102: 82-0153-002-08
• 00889024473096: 82-0153-002-07
• 00889024473089: 82-0153-002-06
• 00889024473072: 82-0153-002-05
• 00889024473065: 82-0153-002-04
• 00889024473058: 82-0153-002-03
• 00889024473041: 82-0153-002-02
• 00889024473034: 82-0153-002-01
• 00889024473027: 82-0153-002-00