NEXGEN® TRABECULAR METAL™ 00-5444-054-46

GUDID 00889024307070

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024307070
• NIH Device Record Key: 47848fba-86eb-438f-a2cb-52daf18e9a70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXGEN® TRABECULAR METAL™
• Version Model Number: 00-5444-054-46
• Catalog Number: 00-5444-054-46
• Company DUNS: 793120965
• Company Name: ZIMMER TRABECULAR METAL TECHNOLOGY 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	00889024307070 [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

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

Moist Heat or Steam Sterilization

[00889024307070]

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: 2016-05-24

On-Brand Devices [NEXGEN® TRABECULAR METAL™]

• 00889024307506: 00-5447-053-36
• 00889024307490: 00-5447-053-31
• 00889024307483: 00-5446-057-46
• 00889024307476: 00-5446-056-46
• 00889024307469: 00-5446-056-41
• 00889024307452: 00-5446-056-36
• 00889024307445: 00-5446-056-31
• 00889024307438: 00-5446-055-46
• 00889024307421: 00-5446-055-41
• 00889024307414: 00-5446-055-36
• 00889024307407: 00-5446-055-31
• 00889024307391: 00-5446-054-46
• 00889024307384: 00-5446-054-41
• 00889024307377: 00-5446-054-36
• 00889024307360: 00-5446-054-31
• 00889024307353: 00-5446-053-36
• 00889024307346: 00-5446-053-31
• 00889024307339: 00-5446-052-36
• 00889024307315: 00-5445-057-46
• 00889024307308: 00-5445-056-46
• 00889024307292: 00-5445-056-41
• 00889024307285: 00-5445-056-36
• 00889024307278: 00-5445-056-31
• 00889024307261: 00-5445-055-46
• 00889024307254: 00-5445-055-41
• 00889024307247: 00-5445-055-36
• 00889024307230: 00-5445-055-31
• 00889024307223: 00-5445-054-46
• 00889024307216: 00-5445-054-41
• 00889024307209: 00-5445-054-36
• 00889024307193: 00-5445-054-31
• 00889024307186: 00-5445-053-36
• 00889024307179: 00-5445-053-31
• 00889024307162: 00-5444-057-46
• 00889024307155: 00-5444-056-46
• 00889024307148: 00-5444-056-41
• 00889024307131: 00-5444-056-36
• 00889024307124: 00-5444-056-31
• 00889024307117: 00-5444-055-46
• 00889024307100: 00-5444-055-41
• 00889024307094: 00-5444-055-36
• 00889024307087: 00-5444-055-31
• 00889024307070: 00-5444-054-46
• 00889024307063: 00-5444-054-41
• 00889024307056: 00-5444-054-36
• 00889024307049: 00-5444-054-31
• 00889024307032: 00-5444-053-36
• 00889024307025: 00-5444-053-31
• 00889024307018: 00-5444-052-36
• 00889024307001: 00-5444-052-31