GPS® III Platelet Concentration System 800-1004A

GUDID 00880304681507

Biomet Biologics, LLC

Haematological concentrate system

• Primary Device ID: 00880304681507
• NIH Device Record Key: dcb5b9cb-72dc-4d5a-92ee-0809d97c707b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GPS® III Platelet Concentration System
• Version Model Number: 800-1004A
• Catalog Number: 800-1004A
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00880304681507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070026

FDA Product Code

• KSS: SUPPLIES, BLOOD-BANK

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-14
• Device Publish Date: 2018-11-13

On-Brand Devices [GPS® III Platelet Concentration System]

• 00880304681514: 800-1007A
• 00880304681507: 800-1004A
• 00880304681491: 800-1003A
• 00880304641068: 800-1006A