G7® ACETABULAR LINER 010000984

GUDID 00880304989085

Biomet Orthopedics, LLC

Constrained polyethylene acetabular liner

• Primary Device ID: 00880304989085
• NIH Device Record Key: d81e281f-7be4-4588-b966-01cfff1e4fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7® ACETABULAR LINER
• Version Model Number: 010000984
• Catalog Number: 010000984
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00880304989085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121874

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-29
• Device Publish Date: 2017-05-10

On-Brand Devices [G7® ACETABULAR LINER]

• 00880304989122: 010000988
• 00880304989115: 010000987
• 00880304989108: 010000986
• 00880304989092: 010000985
• 00880304989085: 010000984
• 00880304989078: 010000983
• 00880304989061: 010000982
• 00880304989054: 010000981
• 00880304989047: 010000980