G7 DUAL MOBILITY 110027713

GUDID 00880304734944

Biomet Orthopedics, LLC

Femoral head prosthesis trial

• Primary Device ID: 00880304734944
• NIH Device Record Key: 13ea5378-3712-44c1-8c77-2aadd75e32f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 DUAL MOBILITY
• Version Model Number: 110027713
• Catalog Number: 110027713
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304734944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150522

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00880304734944]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [G7 DUAL MOBILITY]

• 00880304734951: 110026614
• 00880304734944: 110027713
• 00880304712928: 110024736
• 00880304712911: 110024735
• 00880304712904: 110024734
• 00880304712898: 110024733
• 00880304712881: 110024732
• 00880304712874: 110024731
• 00880304712867: 110024730
• 00880304712850: 110024729
• 00880304712843: 110024728
• 00880304712829: 110024727