Gender Solutions® Natural-Knee® Prolong® 00-5428-010-13

GUDID 00889024190436

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024190436
• NIH Device Record Key: d0330d0b-0487-47dd-b397-0bb68af9e385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gender Solutions® Natural-Knee® Prolong®
• Version Model Number: 00-5428-010-13
• Catalog Number: 00-5428-010-13
• 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

• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024190436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070214

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: 5
• Public Version Date: 2019-09-12
• Device Publish Date: 2015-09-17

On-Brand Devices [Gender Solutions® Natural-Knee® Prolong®]

• 00889024190696: 00-5428-023-16
• 00889024190658: 00-5428-021-19
• 00889024190641: 00-5428-021-16
• 00889024190610: 00-5428-021-09
• 00889024190597: 00-5428-020-16
• 00889024190580: 00-5428-020-13
• 00889024190566: 00-5428-020-09
• 00889024190559: 00-5428-013-19
• 00889024190528: 00-5428-013-11
• 00889024190016: 00-5424-023-09
• 00889024189881: 00-5424-013-13
• 00889024189867: 00-5424-013-09
• 00889024189843: 00-5424-011-16
• 00889024189836: 00-5424-011-13
• 00889024189812: 00-5424-011-09
• 00889024189799: 00-5424-010-16
• 00889024189782: 00-5424-010-13
• 00889024190603: 00-5428-020-19
• 00889024190573: 00-5428-020-11
• 00889024190542: 00-5428-013-16
• 00889024190535: 00-5428-013-13
• 00889024190511: 00-5428-013-09
• 00889024190504: 00-5428-011-19
• 00889024190467: 00-5428-011-09
• 00889024190450: 00-5428-010-19
• 00889024190023: 00-5424-023-11
• 00889024189980: 00-5424-021-13
• 00889024189874: 00-5424-013-11
• 00889024189850: 00-5424-011-19
• 00889024189829: 00-5424-011-11
• 00889024189805: 00-5424-010-19
• 00889024190702: 00-5428-023-19
• 00889024190689: 00-5428-023-13
• 00889024190672: 00-5428-023-11
• 00889024190665: 00-5428-023-09
• 00889024190634: 00-5428-021-13
• 00889024190627: 00-5428-021-11
• 00889024190498: 00-5428-011-16
• 00889024190481: 00-5428-011-13
• 00889024190474: 00-5428-011-11
• 00889024190443: 00-5428-010-16
• 00889024190436: 00-5428-010-13
• 00889024190429: 00-5428-010-11
• 00889024190412: 00-5428-010-09
• 00889024190054: 00-5424-023-19
• 00889024190047: 00-5424-023-16
• 00889024190030: 00-5424-023-13
• 00889024190009: 00-5424-021-19
• 00889024189997: 00-5424-021-16
• 00889024189973: 00-5424-021-11