Premier-Total™

GUDID 00889024178014

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024178014
• NIH Device Record Key: 881b9894-6c1f-4702-b2b4-19d1ee24a6ae
• Commercial Distribution Discontinuation: 2017-05-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Premier-Total™
• Version Model Number: 9351-00-100
• 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@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.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	00889024178014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920955

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

[00889024178014]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-20

On-Brand Devices [Premier-Total™]

• 00889024178359: 9352-02-006
• 00889024178342: 9352-02-005
• 00889024178335: 9352-02-004
• 00889024178328: 9352-02-003
• 00889024178311: 9352-02-002
• 00889024178304: 9352-02-001
• 00889024178298: 9352-02-000
• 00889024178274: 9352-00-006
• 00889024178267: 9352-00-005
• 00889024178250: 9352-00-004
• 00889024178243: 9352-00-003
• 00889024178236: 9352-00-002
• 00889024178229: 9352-00-001
• 00889024178212: 9352-00-000
• 00889024178205: 9351-30-019
• 00889024178199: 9351-30-018
• 00889024178182: 9351-30-017
• 00889024178175: 9351-30-016
• 00889024178168: 9351-30-015
• 00889024178151: 9351-30-014
• 00889024178144: 9351-30-013
• 00889024178137: 9351-30-012
• 00889024178120: 9351-30-011
• 00889024178113: 9351-30-010
• 00889024178106: 9351-30-000
• 00889024178090: 9351-01-006
• 00889024178083: 9351-01-005
• 00889024178076: 9351-01-004
• 00889024178069: 9351-01-003
• 00889024178052: 9351-01-002
• 00889024178045: 9351-01-001
• 00889024178038: 9351-01-000
• 00889024178021: 9351-00-135
• 00889024178014: 9351-00-100
• 00889024457867: 9351-00-004