Precision Mixing & Delivery System

GUDID 00889024205574

Zimmer, Inc.

Bone graft delivery kit

• Primary Device ID: 00889024205574
• NIH Device Record Key: 6e345b77-0cec-4105-b8fb-ae8ce2913fe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Mixing & Delivery System
• Version Model Number: 76-6048
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at 15-25 Degrees Celcius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024205574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141245

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [Precision Mixing & Delivery System]

• 00889024205604: 76-6049
• 00889024205598: 76-6050
• 00889024205581: 76-6047
• 00889024205574: 76-6048