NCB® PERIPROSTHETIC POLYAXIAL

GUDID 00889024289994

NCB® PP Troch Plate Prov, right, wide

Zimmer GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889024289994
• NIH Device Record Key: 9cad3027-9512-48b2-b710-c8fcc9717263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NCB® PERIPROSTHETIC POLYAXIAL
• Version Model Number: 02.00024.413
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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@zimmer.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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024289994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120772

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

[00889024289994]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2016-09-24

On-Brand Devices [NCB® PERIPROSTHETIC POLYAXIAL]

• 00889024290006: NCB® PP Troch Plate Prov, left, wide
• 00889024289994: NCB® PP Troch Plate Prov, right, wide
• 00889024289987: NCB® PP Troch Plate Prov, left, narrow
• 00889024289970: NCB® PP Troch Plate Prov, right, narrow