G7 FREEDOM 31-127019

GUDID 00880304607170

Biomet Orthopedics, LLC

Femoral head prosthesis trial

• Primary Device ID: 00880304607170
• NIH Device Record Key: 31d94389-5f67-4add-a94d-834d2831436b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 FREEDOM
• Version Model Number: 31-127019
• Catalog Number: 31-127019
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304607170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030047

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

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

[00880304607170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-22

On-Brand Devices [G7 FREEDOM]

• 00880304607194: 31-127021
• 00880304607187: 31-127020
• 00880304607170: 31-127019
• 00880304607163: 31-127018
• 00880304607156: 31-127017
• 00880304607149: 31-127016