Identity
- Trade Name
- WoundClot Hemostatic Gauze FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
- Device Name
- WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions. FDA UDI
- Model / Reference
- 4"X4" OTC FDA FDA UDI
- Description
- WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions. FDA UDI
Identifiers
- Catalog Number
- 101511901 FDA UDI
- Primary DI / UDI-DI
- 07290016339376 FDA UDI
- 510(k) Number
- K160679 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
No
FDA UDI
Over-the-Counter
Yes
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
K160679 also covers:
- BleedBloc Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- BleedBloc Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- BleedBloc Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- BleedBloc Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD
- BleedBloc 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 9e2c4ddb-7e38-49a0-ab3c-5d0d842a3cf4 37 fields · synced May 30, 2026