REACH® REVISION HIP SYSTEM 11-162113

GUDID 00880304839021

Biomet Orthopedics, LLC

Revision coated hip femur prosthesis

• Primary Device ID: 00880304839021
• NIH Device Record Key: 0b3388aa-ef3d-4195-af36-b9b146f2b9f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REACH® REVISION HIP SYSTEM
• Version Model Number: 11-162113
• Catalog Number: 11-162113
• 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	00880304839021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971824

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: 2016-10-14

On-Brand Devices [REACH® REVISION HIP SYSTEM]

• 00880304839243: 162120
• 00880304839236: 162119
• 00880304839229: 162118
• 00880304839212: 162117
• 00880304839205: 162116
• 00880304839199: 162115
• 00880304839182: 162114
• 00880304839175: 162113
• 00880304839168: 162112
• 00880304839151: 162111
• 00880304839144: 12-162119
• 00880304839137: 12-162117
• 00880304839120: 12-162115
• 00880304839113: 12-162113
• 00880304839106: 12-162111
• 00880304839090: 11-162120
• 00880304839083: 11-162119
• 00880304839076: 11-162118
• 00880304839069: 11-162117
• 00880304839052: 11-162116
• 00880304839045: 11-162115
• 00880304839038: 11-162114
• 00880304839021: 11-162113
• 00880304839014: 11-162112
• 00880304839007: 11-162111