G7 FREEDOM PROVISIONAL HEAD TYPE 1 110010724

GUDID 00880304569041

Biomet Orthopedics, LLC

Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial

• Primary Device ID: 00880304569041
• NIH Device Record Key: 62309824-0eae-4c9e-bdbf-7a9b02f041b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 FREEDOM PROVISIONAL HEAD TYPE 1
• Version Model Number: 110010724
• Catalog Number: 110010724
• 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	00880304569041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140669
• Premarket Notification: K142882

FDA Product Code

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

Sterilization

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

[00880304569041]

Moist Heat or Steam Sterilization

[00880304569041]

Moist Heat or Steam Sterilization

[00880304569041]

Moist Heat or Steam Sterilization

[00880304569041]

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 1]

• 00880304569096: 110010729
• 00880304569089: 110010728
• 00880304569072: 110010727
• 00880304569058: 110010725
• 00880304569041: 110010724