Continuum® Trilogy® Allofit® Vivacit-E®

GUDID 00889024155442

Zimmer, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00889024155442
• NIH Device Record Key: 75ef54c8-f33f-452a-98d0-5c3e91b9f53f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Continuum® Trilogy® Allofit® Vivacit-E®
• Version Model Number: 00-8852-006-28
• 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@zimmer.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
• 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
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024155442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120370

FDA Product Code

• OQI: Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-17

On-Brand Devices [Continuum® Trilogy® Allofit® Vivacit-E®]

• 00889024155862: 00-8852-023-36
• 00889024155855: 00-8852-023-32
• 00889024155848: 00-8852-022-36
• 00889024155831: 00-8852-022-32
• 00889024155824: 00-8852-021-36
• 00889024155800: 00-8852-020-36
• 00889024155794: 00-8852-020-32
• 00889024155787: 00-8852-019-36
• 00889024155817: 00-8852-021-32
• 00889024155770: 00-8852-019-32
• 00889024155763: 00-8852-018-36
• 00889024155756: 00-8852-018-32
• 00889024155749: 00-8852-018-28
• 00889024155732: 00-8852-017-36
• 00889024155725: 00-8852-017-32
• 00889024155718: 00-8852-017-28
• 00889024155701: 00-8852-016-36
• 00889024155695: 00-8852-016-32
• 00889024155688: 00-8852-016-28
• 00889024155671: 00-8852-015-36
• 00889024155664: 00-8852-015-32
• 00889024155657: 00-8852-015-28
• 00889024155640: 00-8852-014-36
• 00889024155633: 00-8852-014-32
• 00889024155626: 00-8852-014-28
• 00889024155619: 00-8852-013-36
• 00889024155602: 00-8852-013-32
• 00889024155596: 00-8852-013-28
• 00889024155589: 00-8852-012-36
• 00889024155572: 00-8852-012-32
• 00889024155565: 00-8852-012-28
• 00889024155558: 00-8852-011-36
• 00889024155541: 00-8852-011-32
• 00889024155534: 00-8852-011-28
• 00889024155527: 00-8852-010-36
• 00889024155510: 00-8852-010-32
• 00889024155503: 00-8852-010-28
• 00889024155497: 00-8852-009-32
• 00889024155480: 00-8852-009-28
• 00889024155473: 00-8852-008-32
• 00889024155466: 00-8852-008-28
• 00889024155459: 00-8852-007-28
• 00889024155442: 00-8852-006-28
• 00889024155435: 00-8851-023-40
• 00889024155428: 00-8851-023-36
• 00889024155411: 00-8851-023-32
• 00889024155404: 00-8851-022-40
• 00889024155398: 00-8851-022-36
• 00889024155381: 00-8851-022-32
• 00889024155374: 00-8851-021-40