GUDID 00889024111547

Drill guide for 3.2 drill Sys4.0

Zimmer GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889024111547
• NIH Device Record Key: ba50be72-477e-46ab-a853-1d0a420fd768
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 503004047
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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@zimmer.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024111547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123347

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00889024111547]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Zimmer GmbH

• 00889024593152 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593176 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593183 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593190 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593206 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593213 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593237 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593251 - Wagner Cone Prosthesis®: 2023-12-20