PLR HIP SYSTEM 11-158315

GUDID 00880304208254

Biomet Orthopedics, LLC

Revision uncoated femoral stem prosthesis

• Primary Device ID: 00880304208254
• NIH Device Record Key: 9b43f854-57e7-41f0-a50c-ed541765109a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLR HIP SYSTEM
• Version Model Number: 11-158315
• Catalog Number: 11-158315
• 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	00880304208254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994184

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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 [PLR HIP SYSTEM]

• 00880304208346: 11-158324
• 00880304208339: 11-158323
• 00880304208322: 11-158322
• 00880304208315: 11-158321
• 00880304208308: 11-158320
• 00880304208292: 11-158319
• 00880304208285: 11-158318
• 00880304208278: 11-158317
• 00880304208261: 11-158316
• 00880304208254: 11-158315
• 00880304208247: 11-158314