Prolong® NexGen® 00-5952-030-14

GUDID 00889024207981

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024207981
• NIH Device Record Key: cd340d6f-aaef-4d00-9571-ee4ff2ba420b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prolong® NexGen®
• Version Model Number: 5952-30-14
• Catalog Number: 00-5952-030-14
• 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: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024207981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003910

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 [Prolong® NexGen®]

• 00889024263482: 90-5952-50-20
• 00889024263475: 90-5952-50-17
• 00889024263468: 90-5952-40-20
• 00889024263451: 90-5952-40-17
• 00889024263444: 90-5952-30-20
• 00889024263420: 90-5952-21-20
• 00889024208087: 5952-50-14
• 00889024207912: 5952-21-10
• 00889024263437: 90-5952-30-17
• 00889024263413: 90-5952-21-17
• 00889024208025: 5952-40-12
• 00889024207998: 5952-30-17
• 00889024207950: 5952-21-20
• 00889024208100: 5952-50-20
• 00889024208094: 5952-50-17
• 00889024208070: 5952-50-12
• 00889024208063: 5952-50-10
• 00889024208056: 5952-40-20
• 00889024208049: 5952-40-17
• 00889024208032: 5952-40-14
• 00889024208018: 5952-40-10
• 00889024208001: 5952-30-20
• 00889024207981: 5952-30-14
• 00889024207974: 5952-30-12
• 00889024207967: 5952-30-10
• 00889024207943: 5952-21-17
• 00889024207936: 5952-21-14
• 00889024207929: 5952-21-12