Identity
- Trade Name
- WoundClot Hemostatic Gauze FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
- Device Name
- WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding. FDA UDI
- Model / Reference
- 4"X4" FDA FDA UDI
- Description
- WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding. FDA UDI
Identifiers
- Catalog Number
- 101011901 FDA UDI
- Primary DI / UDI-DI
- 07290016339086 FDA UDI
- 510(k) Number
- K140573 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot Hemostatic Gauze by Core Scientific Creations Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plant polysaccharide haemostatic agent, bioabsorbable.
- EndoClot PHS — EndoClot Plus, Inc.
- SURGICEL FIBRILLAR — Ethicon Sàrl · Class III
- StopsBleeding™ — Coag Medical, LLC · U
- SURGICEL FIBRILLAR — Ethicon Inc. · Class III
- Benacel Plus — UNICARE BIOMEDICAL, INC. · U
- BleedStop™ — Coag Medical, LLC · U
- BleedStop™ — Coag Medical, LLC · U
- ETHICON — Ethicon Inc. · Class III
Cleared under the same submission
K140573 also covers:
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Core Scientific Creations Ltd
Sources (1)
- FDA UDI 6fef31e9-1eb2-41e1-a712-e8d3786c8bd4 37 fields · synced May 30, 2026