AccuZone (Assisted FreeHand Guide) 323.100

GUDID 00889024406469

ZIMMER KNEE CREATIONS, INC.

Surgical drill guide, single-use

• Primary Device ID: 00889024406469
• NIH Device Record Key: bfef7acb-f71e-4d85-8276-7aa1ad59d1a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuZone (Assisted FreeHand Guide)
• Version Model Number: 323.100
• Catalog Number: 323.100
• Company DUNS: 078836317
• Company Name: ZIMMER KNEE CREATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024406469 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-05-19

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