ECHO PRESS-FIT HIP SYSTEM 12-150314

GUDID 00880304467835

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00880304467835
• NIH Device Record Key: 98293bc9-b603-4fca-ab1f-b914b565a5e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHO PRESS-FIT HIP SYSTEM
• Version Model Number: 12-150314
• Catalog Number: 12-150314
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304467835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063002

FDA Product Code

• MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

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: 2015-10-24

On-Brand Devices [ECHO PRESS-FIT HIP SYSTEM]

• 00880304467903: 12-150312
• 00880304467897: 12-150317
• 00880304467880: 12-150308
• 00880304467873: 12-150315
• 00880304467866: 12-150310
• 00880304467859: 12-150316
• 00880304467842: 12-150313
• 00880304467835: 12-150314
• 00880304467828: 12-150307
• 00880304464155: 12-150311
• 00880304457560: 12-150309