Zimmer® DTO®

GUDID 00889024284456

Zimmer® DTO® Pin press

Zimmer GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889024284456
• NIH Device Record Key: 78517673-3c7c-4105-968a-b7e1ba3d8be8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer® DTO®
• Version Model Number: 01.03799.058
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024284456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101704

FDA Product Code

• NQP: POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Sterilization

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

[00889024284456]

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: 2016-08-29

On-Brand Devices [Zimmer® DTO®]

• 00889024487741: 01.03791.090
• 00889024487734: 01.03791.070
• 00889024485051: 01.03791.080
• 00889024485044: 01.03791.060
• 00889024485037: 01.03791.050
• 00889024485020: 01.03791.040
• 00889024485013: 01.03791.100
• 00889024284456: Zimmer® DTO® Pin press
• 00889024284180: Zimmer DTO Implant 100
• 00889024284173: Zimmer DTO Implant 90
• 00889024284166: Zimmer DTO Implant 80
• 00889024284159: Zimmer DTO Implant 70
• 00889024284142: Zimmer DTO Implant 60
• 00889024284135: Zimmer DTO Implant 50
• 00889024284128: Zimmer DTO Implant 40