Perfuse™ Decompression System 800-0544

GUDID 00887868263057

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00887868263057
• NIH Device Record Key: 21eca438-9b82-4002-a50b-c10d389cf46d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfuse™ Decompression System
• Version Model Number: 800-0544
• Catalog Number: 800-0544
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868263057 [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

[00887868263057]

Moist Heat or Steam Sterilization

[00887868263057]

Moist Heat or Steam Sterilization

[00887868263057]

Moist Heat or Steam Sterilization

[00887868263057]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [Perfuse™ Decompression System]

• 00887868263071: 800-0546
• 00887868263064: 800-0545
• 00887868263057: 800-0544
• 00887868263040: 800-0543
• 00887868263033: 800-0542
• 00887868263026: 800-0541