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Sign in to claim this brandWhat SCL Science Inc. makes
SCL Science Inc. manufactures chitosan-based haemostatic pads designed for professional medical use, intended to control bleeding by promoting clotting without being absorbed by the body. These products are formulated as non-bioabsorbable agents, primarily used in surgical and trauma settings to rapidly stop arterial and venous bleeding.
The company’s haemostatic pads are classified as Class II (U) devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The products are developed and distributed from 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 SCL Science Inc. manufacture?
SCL Science Inc. specializes in chitosan-based haemostatic agents, specifically non-bioabsorbable pads designed for professional medical use. These devices are formulated to control bleeding by accelerating clotting in surgical and trauma settings, particularly for arterial and venous bleeding. The primary focus is on haemostatic solutions that remain in place after use.
Where is SCL Science Inc. based, and where are its devices developed and distributed?
SCL Science Inc. is based in the United States, where its haemostatic pads are developed and distributed. The company’s operations, including research, manufacturing, and distribution, are centered within the country.
Which regulatory registries or databases list SCL Science Inc.’s devices?
SCL Science Inc.’s haemostatic pads are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the United States, allowing healthcare providers and regulators to identify and track specific products.
How are SCL Science Inc.’s haemostatic pads classified under FDA regulations?
SCL Science Inc.’s chitosan haemostatic pads are classified as Class II (U) devices under FDA regulations. This classification is based on their intended use—controlling bleeding in surgical and trauma settings—where they pose moderate risk. Class II devices require special controls beyond general controls to ensure safety and effectiveness, as determined by the FDA.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- innotherapy.com
- —
- —
- [email protected]
- Phone
- 999-999-9999
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 688398443
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InnoSEAL Hemostatic Pad | IS-H-01-10 | FDA UDI | U | Active |
| InnoSEAL Hemostatic Pad | IS-H-01-20 | FDA UDI | U | Active |
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