Natural-Knee® Durasul® 6276-00-613

GUDID 00889024255845

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024255845
• NIH Device Record Key: 4785b014-b750-473d-92a4-2926a45f3978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natural-Knee® Durasul®
• Version Model Number: 6276-00-613
• Catalog Number: 6276-00-613
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024255845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002335

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-25
• Device Publish Date: 2015-09-17

On-Brand Devices [Natural-Knee® Durasul®]

• 00889024256118: 6276-02-719
• 00889024256101: 6276-02-716
• 00889024256095: 6276-02-713
• 00889024256088: 6276-02-711
• 00889024256071: 6276-02-709
• 00889024256064: 6276-02-619
• 00889024256057: 6276-02-616
• 00889024256040: 6276-02-613
• 00889024256033: 6276-02-611
• 00889024256026: 6276-02-609
• 00889024256019: 6276-01-719
• 00889024256002: 6276-01-716
• 00889024255999: 6276-01-713
• 00889024255982: 6276-01-711
• 00889024255975: 6276-01-709
• 00889024255968: 6276-01-619
• 00889024255951: 6276-01-616
• 00889024255944: 6276-01-613
• 00889024255937: 6276-01-611
• 00889024255920: 6276-01-609
• 00889024255913: 6276-00-719
• 00889024255906: 6276-00-716
• 00889024255890: 6276-00-713
• 00889024255883: 6276-00-711
• 00889024255876: 6276-00-709
• 00889024255869: 6276-00-619
• 00889024255852: 6276-00-616
• 00889024255845: 6276-00-613
• 00889024255838: 6276-00-611
• 00889024255821: 6276-00-609