STANMORE HIP SYSTEM 12-164242

GUDID 00880304223431

Biomet Orthopedics, LLC

Uncoated hip femur prosthesis, modular

• Primary Device ID: 00880304223431
• NIH Device Record Key: faa48675-928b-45cf-a2f1-9f9826445d99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STANMORE HIP SYSTEM
• Version Model Number: 12-164242
• Catalog Number: 12-164242
• 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	00880304223431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911684

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 [STANMORE HIP SYSTEM]

• 00880304257283: 164240
• 00880304257276: 164239
• 00880304257269: 164238
• 00880304257252: 164237
• 00880304257245: 164236
• 00880304223431: 12-164242