NexGen®

GUDID 00889024216501

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024216501
• NIH Device Record Key: 761eb1a4-40a5-4bc1-8888-fe86f814bf78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen®
• Version Model Number: 5977-56-01
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024216501 [Primary]
GS1	00889024398733 [Unit of Use]
GS1	70889024216500 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

[00889024216501]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-10

On-Brand Devices [NexGen®]

• 00889024196377: 00-5850-075-16
• 00889024196360: 00-5850-075-15
• 00889024196353: 00-5850-075-14
• 00889024196346: 00-5850-075-13
• 00889024196339: 00-5850-075-12
• 00889024563896: 5990-35-24
• 00889024563889: 5990-35-02
• 00889024563872: 5990-34-21
• 00889024563865: 5990-34-10
• 00889024563858: 5990-33-31
• 00889024563841: 5990-33-20
• 00889024263673: 90-5970-50-09
• 00889024263611: 90-5970-40-09
• 00889024263550: 90-5970-30-09
• 00889024263499: 90-5970-21-09
• 00889024221130: 5988-12-12
• 00889024221123: 5988-11-18
• 00889024221116: 5988-11-17
• 00889024221109: 5988-11-16
• 00889024221093: 5988-11-15
• 00889024221086: 5988-11-14
• 00889024221079: 5988-11-13
• 00889024221062: 5988-11-12
• 00889024221055: 5988-10-24
• 00889024221048: 5988-10-22
• 00889024221031: 5988-10-20
• 00889024221024: 5988-10-18
• 00889024221017: 5988-10-17
• 00889024221000: 5988-10-16
• 00889024220997: 5988-10-15
• 00889024220980: 5988-10-14
• 00889024220966: 5988-10-12
• 00889024220959: 5988-10-11
• 00889024220942: 5988-10-10
• 00889024220218: 5988-03
• 00889024215177: 5972-65-41
• 00889024215160: 5972-65-38
• 00889024215153: 5972-65-35
• 00889024215146: 5972-65-32
• 00889024215139: 5972-65-29
• 00889024215122: 5972-65-26
• 00889024214477: 5970-50-09
• 00889024214392: 5970-40-09
• 00889024214316: 5970-30-09
• 00889024214224: 5970-21-09
• 00889024212350: 5966-04-17
• 00889024212343: 5966-04-14
• 00889024212336: 5966-04-12
• 00889024212329: 5966-04-10
• 00889024212312: 5966-03-17