APR® 4338-28-047

GUDID 00889024644021

Zimmer, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00889024644021
• NIH Device Record Key: 9a9a4f08-e6f1-4117-8f74-d077d3f92e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APR®
• Version Model Number: 4338-28-047
• Catalog Number: 4338-28-047
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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)348-2759
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 47 Millimeter
• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024644021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941617

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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: 2022-03-07
• Device Publish Date: 2022-02-25

On-Brand Devices [APR®]

• 00889024182691: 9400-99-211
• 00889024182684: 9400-99-210
• 00889024182677: 9400-99-201
• 00889024182660: 9400-99-200
• 00889024182639: 9400-00-100
• 00889024182622: 9400-00-030
• 00889024177994: 9326-00-103
• 00889024177987: 9326-00-002
• 00889024177970: 9326-00-001
• 00889024177956: 9310-10-201
• 00889024177895: 9310-10-102
• 00889024177871: 9306-05-070
• 00889024177864: 9306-05-068
• 00889024177857: 9306-05-066
• 00889024177840: 9306-05-064
• 00889024177833: 9306-05-062
• 00889024177826: 9306-05-060
• 00889024177819: 9306-05-058
• 00889024177802: 9306-05-056
• 00889024177796: 9306-05-054
• 00889024177789: 9306-05-052
• 00889024177772: 9306-05-050
• 00889024177765: 9306-05-048
• 00889024177758: 9306-05-046
• 00889024177741: 9306-05-044
• 00889024177734: 9306-05-042
• 00889024177727: 9306-01-004
• 00889024177710: 9306-01-003
• 00889024177703: 9306-01-001
• 00889024177697: 9306-00-003
• 00889024177680: 9301-10-101
• 00889024177673: 9301-01-003
• 00889024177666: 9301-01-001
• 00889024177659: 9301-00-004
• 00889024177642: 9301-00-002
• 00889024177604: 9300-00-001
• 00889024177185: 9200-99-006
• 00889024176591: 9200-01-203
• 00889024166998: 4338-32-067
• 00889024166981: 4338-32-065
• 00889024166974: 4338-32-063
• 00889024166967: 4338-32-061
• 00889024166950: 4338-32-059
• 00889024166943: 4338-32-057
• 00889024166936: 4338-32-055
• 00889024166929: 4338-32-053
• 00889024166912: 4338-32-051
• 00889024166905: 4338-28-067
• 00889024166899: 4338-28-065
• 00889024166882: 4338-28-063