Tropocells®, Eclipse PRP, Healeon PRP 12531102GLVAS

GUDID 07290015874014

ESTAR TECHNOLOGIES LTD

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration 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