COMPREHENSIVE SRS REVISION 405231

GUDID 00880304542365

Biomet Orthopedics, LLC

Orthopaedic implant impactor

• Primary Device ID: 00880304542365
• NIH Device Record Key: 03fffac8-8cf6-49fd-9340-983102ba56b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE SRS REVISION
• Version Model Number: 405231
• Catalog Number: 405231
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304542365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111746

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00880304542365]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-27

On-Brand Devices [COMPREHENSIVE SRS REVISION]

• 00880304542457: 405230
• 00880304542365: 405231