NexGen® Trabecular Metal™ 00-5444-050-00

GUDID 00889024191013

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024191013
• NIH Device Record Key: 4dd1aed3-15f1-4de4-9f20-0b0b30057a87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen® Trabecular Metal™
• Version Model Number: 00-5444-050-00
• Catalog Number: 00-5444-050-00
• 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: 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024191013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120990

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

[00889024191013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2016-08-11

On-Brand Devices [NexGen® Trabecular Metal™]

• 00889024208285: 00-5954-057-01
• 00889024208292: 00-5954-057-02
• 00889024191020: 00-5445-050-00
• 00889024191013: 00-5444-050-00
• 00889024208278: 00-5954-047-02
• 00889024208261: 00-5954-047-01
• 00889024208254: 00-5954-037-02
• 00889024208247: 00-5954-037-01
• 00889024208308: 00-5954-080-00
• 00889024208216: 00-5953-056-06
• 00889024208209: 00-5953-056-00
• 00889024208193: 00-5953-054-00
• 00889024208186: 00-5953-036-00
• 00889024208179: 00-5953-012-08
• 00889024208162: 00-5953-012-07
• 00889024208155: 00-5953-012-06
• 00889024208148: 00-5953-012-05
• 00889024208131: 00-5953-012-04
• 00889024208124: 00-5953-012-03
• 00889024208117: 00-5953-012-02