BIO-MOORE II HIP SYSTEM 139204

GUDID 00880304228214

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304228214
• NIH Device Record Key: 6ebfefe6-8b26-4625-a985-b2d2c5b757f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-MOORE II HIP SYSTEM
• Version Model Number: 139204
• Catalog Number: 139204
• 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	00880304228214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K845025

FDA Product Code

• KWL: Prosthesis, hip, hemi-, femoral, metal

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 [BIO-MOORE II HIP SYSTEM]

• 00880304228290: 139241
• 00880304228269: 139211
• 00880304228245: 139210
• 00880304228221: 139205
• 00880304228214: 139204
• 00880304228184: 139202
• 00880304068100: CP200157
• 00880304000735: 139209
• 00880304000148: 139203