Tropocells®, Eclipse PRP, Healeon PRP 12531102GLVAS

GUDID 07290015874014

ESTAR TECHNOLOGIES LTD

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 07290015874014
• NIH Device Record Key: 3d4d0363-d75a-462e-86c3-467959c13d68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tropocells®, Eclipse PRP, Healeon PRP
• Version Model Number: 12531102GLVAS
• Catalog Number: 12531102GLVAS
• Company DUNS: 600278550
• Company Name: ESTAR TECHNOLOGIES LTD
• 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: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com
• Phone: +97235596414
• Email: Aaron@estar-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015874014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK110035

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-07
• Device Publish Date: 2016-10-19

On-Brand Devices [Tropocells®, Eclipse PRP, Healeon PRP]

• 07290015874502: PPK3B
• 07290015874045: 14532205GLVAS
• 07290015874038: 14522205GLVAS
• 07290015874014: 12531102GLVAS
• 07290015874007: 12521102GLVAS