BALANCE MICROPLASTY HIP SYSTEM 180223

GUDID 00880304455436

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular

• Primary Device ID: 00880304455436
• NIH Device Record Key: 82c3799c-efab-4275-bc2a-aceb3367e64d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALANCE MICROPLASTY HIP SYSTEM
• Version Model Number: 180223
• Catalog Number: 180223
• 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	00880304455436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050251

FDA Product Code

• LZY: Prosthesis, hip, hemi-, femoral, metal ball

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 [BALANCE MICROPLASTY HIP SYSTEM]

• 00880304455474: 180218
• 00880304455467: 180224
• 00880304455450: 180217
• 00880304455443: 180227
• 00880304455436: 180223
• 00880304455429: 180219
• 00880304455412: 180222
• 00880304455405: 180220
• 00880304455399: 180226
• 00880304455382: 180216
• 00880304455375: 180221
• 00880304455368: 180225
• 00880304446489: 180207
• 00880304446472: 180215
• 00880304446465: 180212
• 00880304446458: 180209
• 00880304446441: 180205
• 00880304446434: 180213
• 00880304446427: 180202
• 00880304446410: 180206
• 00880304446403: 180203
• 00880304446397: 180210
• 00880304446380: 180211
• 00880304446373: 180200
• 00880304446366: 180214
• 00880304446359: 180201
• 00880304446342: 180204
• 00880304446335: 180208