OSS / COMPRESS DEVICE 178550

GUDID 00880304260757

Biomet Orthopedics, LLC

Knee stem

• Primary Device ID: 00880304260757
• NIH Device Record Key: f6e1e9c0-deaf-4d85-acda-5039d22d0c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS / COMPRESS DEVICE
• Version Model Number: 178550
• Catalog Number: 178550
• 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	00880304260757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041352

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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: 4
• Public Version Date: 2019-05-22
• Device Publish Date: 2015-10-24

On-Brand Devices [OSS / COMPRESS DEVICE]

• 00880304260757: 178550
• 00880304260740: 178549
• 00880304260733: 178548