BIOLOX® Delta Hip System 12-115109

GUDID 00887868248405

Biomet Orthopedics, LLC

Ceramic femoral head prosthesis

• Primary Device ID: 00887868248405
• NIH Device Record Key: e86f2767-41e8-4cca-bebd-153ab7de6cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX® Delta Hip System
• Version Model Number: 12-115109
• Catalog Number: 12-115109
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868248405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042091

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-17
• Device Publish Date: 2018-11-13

On-Brand Devices [BIOLOX® Delta Hip System]

• 00887868248559: 12-115134
• 00887868248542: 12-115133
• 00887868248535: 12-115132
• 00887868248528: 12-115131
• 00887868248511: 12-115130
• 00887868248504: 12-115123
• 00887868248498: 12-115122
• 00887868248481: 12-115121
• 00887868248474: 12-115120
• 00887868248467: 12-115117
• 00887868248450: 12-115116
• 00887868248443: 12-115115
• 00887868248436: 12-115114
• 00887868248429: 12-115111
• 00887868248412: 12-115110
• 00887868248405: 12-115109
• 00887868248603: 650-1059
• 00887868248597: 650-1058
• 00887868248580: 650-1057
• 00887868248573: 650-1056