G7 FREEDOM PROVISIONAL HEAD TYPE 12/14 110010726

GUDID 00880304569065

Biomet Orthopedics, LLC

Femoral head prosthesis trial

• Primary Device ID: 00880304569065
• NIH Device Record Key: 4454616a-10d5-4b28-9950-77b419295439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 FREEDOM PROVISIONAL HEAD TYPE 12/14
• Version Model Number: 110010726
• Catalog Number: 110010726
• 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: true
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304569065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133940
• Premarket Notification: K142882

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

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

[00880304569065]

Moist Heat or Steam Sterilization

[00880304569065]

Moist Heat or Steam Sterilization

[00880304569065]

Moist Heat or Steam Sterilization

[00880304569065]

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: 2016-10-28

On-Brand Devices [G7 FREEDOM PROVISIONAL HEAD TYPE 12/14]

• 00880304707535: 31-137021
• 00880304707528: 31-137020
• 00880304707511: 31-137019
• 00880304707504: 31-137017
• 00880304707498: 31-137016
• 00880304707481: 31-137018
• 00880304569102: 110010731
• 00880304569065: 110010726
• 00880304569034: 110010723
• 00880304569027: 110010722