OSS BOWED IM TOTAL FEMUR ROD TRIAL 110024557

GUDID 00880304687868

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304687868
• NIH Device Record Key: b6a39028-90f9-46d1-87df-83febbbc65ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS BOWED IM TOTAL FEMUR ROD TRIAL
• Version Model Number: 110024557
• Catalog Number: 110024557
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304687868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152621

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304687868]

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: 2017-07-28

On-Brand Devices [OSS BOWED IM TOTAL FEMUR ROD TRIAL]

• 00880304687936: 110024564
• 00880304687929: 110024563
• 00880304687912: 110024562
• 00880304687905: 110024561
• 00880304687899: 110024560
• 00880304687882: 110024559
• 00880304687875: 110024558
• 00880304687868: 110024557
• 00880304687851: 110024556
• 00880304687844: 110024555
• 00880304687837: 110024554