OXFORD FIXED 32-423336

GUDID 00880304543515

Biomet Orthopedics, LLC

Surgical implant template, reusable

• Primary Device ID: 00880304543515
• NIH Device Record Key: d20af82d-f1db-4e85-a066-87830cc7773e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXFORD FIXED
• Version Model Number: 32-423336
• Catalog Number: 32-423336
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304543515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122277

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00880304543515]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [OXFORD FIXED]

• 00880304609938: 32-423349
• 00880304609921: 32-423348
• 00880304609914: 32-423347
• 00880304609907: 32-423346
• 00880304609877: 32-423335
• 00880304609860: 32-423334
• 00880304543515: 32-423336
• 00880304543508: 32-423331
• 00880304543492: 32-423354
• 00880304543485: 32-423333
• 00880304543461: 32-423332