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Sign in to claim this brandWhat CORE SCIENTIFIC CREATIONS LTD makes
The company produces bioabsorbable haemostatic gauze made from plant polysaccharides, designed to control bleeding in wound care applications. These products include variations of WoundClot and BleedBloc haemostatic dressings, intended for direct application to bleeding sites to promote rapid clotting.
The haemostatic gauze portfolio falls under FDA Class II (U) devices and is listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Core Scientific Creations Ltd manufacture?
Core Scientific Creations Ltd specializes in bioabsorbable haemostatic gauze made from plant polysaccharides. These products are designed to control bleeding in wound care settings, including variations of WoundClot and BleedBloc haemostatic dressings. The devices are intended for direct application to bleeding sites to accelerate clotting.
Where is Core Scientific Creations Ltd based?
The company is headquartered in the United States. This location is relevant for regulatory and compliance purposes, particularly when assessing device authorisation pathways under applicable US regulations.
Which regulatory registries list Core Scientific Creations Ltd’s devices?
Core Scientific Creations Ltd’s haemostatic gauze products are listed in the FDA’s Unique Device Identification (UDI) database. This registry provides a standardized identifier for tracking and tracing devices, ensuring traceability and compliance with regulatory requirements.
How are Core Scientific Creations Ltd’s haemostatic gauze products classified?
The haemostatic gauze products from Core Scientific Creations Ltd fall under FDA Class II (U) classification. This classification is determined based on the risk associated with the device, where Class II devices require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- wound-clot.com
- —
- —
- [email protected]
- Phone
- +97237359555
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 600041570
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| WoundClot Hemostatic Gauze | 8"X12" FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 8"X12" EMS FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X8" PreHospital FDA | FDA UDI | U | Active |
| BleedBloc Hemostatic Gauze | 4" X 4" (10cm X 10cm) US | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 2"X2" OTC FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 4"X4" FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 8"X12" PreHospital FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 2"X2" FDA | FDA UDI | U | Active |
| BleedBloc Hemostatic Gauze | 3" X 39" (8cm X 100cm) US | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3" X 39" OTC FDA | FDA UDI | U | Unknown |
| WoundClot Hemostatic Gauze | 3"X23.6" OTC FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X8" FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X39" PreHospital FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X8" EMS FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X8" OTC FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 4"X4" OTC FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | TWIN PACK 2"X2" FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 8"X12" OTC FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 4"X4" PreHospital FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X39" EMS FDA | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 3"X39" FDA | FDA UDI | U | Active |
| BleedBloc Hemostatic Gauze | 3" X 8" (8cm X 20cm) US | FDA UDI | U | Active |
| WoundClot Hemostatic Gauze | 4"X4" EMS FDA | FDA UDI | U | Active |
| BleedBloc Hemostatic Gauze | 3" X 24" (8cm X 60cm) US | FDA UDI | U | Active |
| BleedBloc Hemostatic Gauze | Double Pack 2" X 2" (5cm X 5cm) US | FDA UDI | U | Active |
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