TropoCells

Basic Information

• Brand Name: TropoCells
• Primary DI: 07290015874243
• Version / Model: T_ACC22
• Catalog Number: T_ACC22
• Company Name: ESTAR TECHNOLOGIES LTD
• Labeler DUNS: 600278550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-30
• Public Version: 1
• Public Version Date: 2025-10-08
• Public Version Status: New
• Public Device Record Key: a7ec9b31-b99f-4323-a47d-e4e1c66e7e10

Device Description

Accessory Kit for 11ml tube contains : 1. VACU20-Blood collection system 2. Sharp Needle 16G*65mm 3. Vented Needle 18G*38mm 4. Disk filter 5. 10ml Syringes * 2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

GMDN Terms

Code	Name	Definition	Implantable	Status
46923	Haematological concentrate system preparation kit, platelet concentration	A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290015874243	GS1