GUDID 00889024410695

Zimmer, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00889024410695
• NIH Device Record Key: ceaa068d-e34c-4015-8135-ed81f6c898c8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6726-10
• 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@zimmer.com

Device Dimensions

• Lumen/Inner Diameter: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024410695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921308

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-12

Devices Manufactured by Zimmer, Inc.

• 00889024678736 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678743 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678750 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678767 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678774 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678781 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678798 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678804 - OsseoFit™ Stemless Shoulder: 2024-12-26