INTEGRAL REVISION HIP SYSTEM 166041

GUDID 00880304257979

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular

• Primary Device ID: 00880304257979
• NIH Device Record Key: 64683321-f325-4fb0-a46e-8a1ff575522d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRAL REVISION HIP SYSTEM
• Version Model Number: 166041
• Catalog Number: 166041
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304257979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

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: 2015-10-24

On-Brand Devices [INTEGRAL REVISION HIP SYSTEM]

• 00880304258051: 166049
• 00880304258044: 166048
• 00880304258037: 166047
• 00880304258020: 166046
• 00880304258013: 166044
• 00880304258006: 166043
• 00880304257986: 166042
• 00880304257979: 166041
• 00880304257962: 166029
• 00880304257955: 166028
• 00880304257948: 166027
• 00880304257931: 166026
• 00880304257924: 166024
• 00880304257900: 166023
• 00880304257894: 166022
• 00880304007444: 166045
• 00880304000360: 166025
• 00880304000353: 166021