1.5MM/2.0MM SYSTEM 01-7164

GUDID 00841036013264

BIOMET MICROFIXATION, INC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00841036013264
• NIH Device Record Key: 6e35affa-3b77-4c8b-ac0f-f44e26187fda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5MM/2.0MM SYSTEM
• Version Model Number: 01-7164
• Catalog Number: 01-7164
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, 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: 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036013264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036013264]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2015-10-11

On-Brand Devices [1.5MM/2.0MM SYSTEM]

• 00841036016821: 01-9123
• 00841036016791: 01-9095
• 00841036014087: GREEN,SCREWDRIVER HANDLE
• 00841036013264: 01-7164