PERFUSE DECOMPRESSION INSTRUMENTATION 800-0546

GUDID 00880304680333

Biomet Biologics, LLC

Instrument tray

• Primary Device ID: 00880304680333
• NIH Device Record Key: 7f201e85-fdd1-4907-92dc-0a6c28f08ba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERFUSE DECOMPRESSION INSTRUMENTATION
• Version Model Number: 800-0546
• Catalog Number: 800-0546
• 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: 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00880304680333 [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

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

[00880304680333]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-11-03

Devices Manufactured by Biomet Biologics, LLC

• 00880304640962 - Bilateral BMA Kit: 2021-11-08
• 00880304460645 - GPS® III: 2020-02-05
• 00880304460652 - GPS® III: 2020-02-05
• 00880304681477 - BioCUE® Mini Concentration System: 2020-01-24
• 00880304681484 - BioCUE® Concentration System: 2020-01-24
• 00880304680333 - PERFUSE DECOMPRESSION INSTRUMENTATION: 2019-08-09
• 00880304680333 - PERFUSE DECOMPRESSION INSTRUMENTATION: 2019-08-09
• 00880304400085 - Biomet®: 2019-06-19
• 00880304400092 - Plasmax® Counterbalance: 2019-06-19