AccuMix Mixing System 311.100

GUDID 00889024406452

ZIMMER KNEE CREATIONS, INC.

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• Primary Device ID: 00889024406452
• NIH Device Record Key: 3deca2d5-571c-49fb-a0f1-46be9f754d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuMix Mixing System
• Version Model Number: 311.100
• Catalog Number: 311.100
• Company DUNS: 078836317
• Company Name: ZIMMER KNEE CREATIONS, 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: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com
• Phone: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024406452 [Primary]
GS1	00889024406520 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133021

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: 2016-06-02

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