Tropocells 521254US

GUDID 07290015874359

ESTAR TECHNOLOGIES LTD

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• Primary Device ID: 07290015874359
• NIH Device Record Key: b412bcc6-0d58-4ffc-8aba-a2cf0893205f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tropocells
• Version Model Number: 521254US
• Catalog Number: 521254US
• 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	07290015874359 [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: 2016-10-20

On-Brand Devices [Tropocells]

• 07290015874380: ESTSN1650
• 07290015874373: 52FF
• 07290015874359: 521254US
• 07290015874311: ESTSN1690
• 07290015874229: 1253VTSF10
• 07290015874137: 14992905GLA
• 07290015874120: 12991402GLA
• 17290015874202: 06212SC
• 07290015874052: T_PRP11U
• 07290015874175: T_PRP22U
• 07290015874168: T_PRP11U