Select™ 803004401

GUDID 00889024500303

Zimmer, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 00889024500303
• NIH Device Record Key: 724709cf-bed7-4d11-bfe0-a50f2ae22761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Select™
• Version Model Number: 803004401
• Catalog Number: 803004401
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024500303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181761

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [Select™]

• 00889024500471: 803000203
• 00889024500464: 803000202
• 00889024500457: 803000201
• 00889024500440: 803000105
• 00889024500433: 803000104
• 00889024500426: 803000103
• 00889024500419: 803000102
• 00889024500402: 803000101
• 00889024500396: 803000004
• 00889024500389: 803000003
• 00889024500372: 803000002
• 00889024500365: 803000001
• 00889024500358: 803004400
• 00889024500341: 803004000
• 00889024500334: 803003600
• 00889024500327: 803003200
• 00889024500303: 803004401
• 00889024500297: 803004001
• 00889024500280: 803003601
• 00889024500273: 803003201
• 00889024500266: 803002801