G7® Freedom® Vivacit-E® 30213607

GUDID 00889024588516

Zimmer, Inc.

Constrained polyethylene acetabular liner

• Primary Device ID: 00889024588516
• NIH Device Record Key: 91f92d71-4afc-48e2-a47d-e79c7b131367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7® Freedom® Vivacit-E®
• Version Model Number: 30213607
• Catalog Number: 30213607
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024588516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212512

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-25
• Device Publish Date: 2022-05-17

On-Brand Devices [G7® Freedom® Vivacit-E®]

• 00889024588639: 30253610
• 00889024588622: 30253609
• 00889024588615: 30253608
• 00889024588608: 30253607
• 00889024588592: 30253606
• 00889024588585: 30253605
• 00889024588578: 30253604
• 00889024588561: 30253203
• 00889024588554: 30253202
• 00889024588547: 30213610
• 00889024588530: 30213609
• 00889024588523: 30213608
• 00889024588516: 30213607
• 00889024588509: 30213606
• 00889024588493: 30213605
• 00889024588486: 30213604
• 00889024588479: 30213203
• 00889024588462: 30213202
• 00889024588455: 30203610
• 00889024588448: 30203609
• 00889024588431: 30203608
• 00889024588424: 30203607
• 00889024588417: 30203606
• 00889024588400: 30203605
• 00889024588394: 30203604
• 00889024588387: 30203203
• 00889024588370: 30203202