Identity
- Trade Name
- StopsBleeding™ FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
- Device Name
- StopsBleeding™ 10g pouch FDA UDI
- Model / Reference
- SBP0010 FDA UDI
- Description
- StopsBleeding™ 10g pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850817006456 FDA UDI
- 510(k) Number
- K140313 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
No
FDA UDI
Category: Plant polysaccharide haemostatic agent, bioabsorbable
StopsBleeding™ by Coag Medical, LLC — 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.
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
- SURGICEL FIBRILLAR — Ethicon Sàrl · Class III
- SURGICEL FIBRILLAR — Ethicon Inc. · Class III
- Benacel Plus — UNICARE BIOMEDICAL, INC. · U
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
- ETHICON — Ethicon Inc. · Class III
Cleared under the same submission
K140313 also covers:
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
- BleedStop™ — Coag Medical, LLC
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
- Coag Medical, LLC
Sources (1)
- FDA UDI c309e038-ca82-4502-810e-5b3969308bed 34 fields · synced May 30, 2026