PERFUSE STRIKE CAP 800-0544

GUDID 00880304999626

Biomet Biologics, LLC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00880304999626
• NIH Device Record Key: 216f009a-ae10-4471-8682-c397cff2be63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERFUSE STRIKE CAP
• Version Model Number: 800-0544
• Catalog Number: 800-0544
• Company DUNS: 802003074
• Company Name: Biomet Biologics, 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304999626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141762

FDA Product Code

• FMF: Syringe, piston

Sterilization

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

[00880304999626]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-11-03

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• 00880304681477 - BioCUE® Mini Concentration System: 2020-01-24
• 00880304681484 - BioCUE® Concentration System: 2020-01-24
• 00880304680333 - PERFUSE DECOMPRESSION INSTRUMENTATION: 2019-08-09
• 00880304400085 - Biomet®: 2019-06-19
• 00880304400092 - Plasmax® Counterbalance: 2019-06-19