BI-POLAR 31-479571

GUDID 00880304319943

Biomet Orthopedics, LLC

Femoral head prosthesis trial

• Primary Device ID: 00880304319943
• NIH Device Record Key: 61f34111-1b75-4ccb-9a88-e40d923d092a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-POLAR
• Version Model Number: 31-479571
• Catalog Number: 31-479571
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00880304319943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051569

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304319943]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-22

On-Brand Devices [BI-POLAR]

• 00880304319943: 31-479571
• 00880304319912: 31-479564
• 00880304319899: 31-479562
• 00880304319875: 31-479560
• 00880304319868: 31-479559
• 00880304319844: 31-479557
• 00880304319837: 31-479556
• 00880304319813: 31-479554
• 00880304319790: 31-479552
• 00880304319479: 31-479365
• 00880304319462: 31-479285
• 00887868481468: 31-479365
• 00887868479144: 31-401137
• 00887868479137: 31-401136
• 00887868479120: 31-401135
• 00887868479113: 31-401134
• 00887868479106: 31-401133
• 00887868479090: 31-401132
• 00887868479083: 31-401131
• 00880304567740: 110005124
• 00880304567733: 110005123
• 00880304567665: 110005109