Identity
- Trade Name
- ETHICON FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
- Device Name
- Absorbable Hemostatic Powder, Oxidized Regenerated Cellulose FDA UDI
- Model / Reference
- 3013SP FDA UDI
- Description
- Absorbable Hemostatic Powder, Oxidized Regenerated Cellulose FDA UDI
Identifiers
- Catalog Number
- 3013SP FDA UDI
- Primary DI / UDI-DI
- 10705031237506 FDA UDI
- FDA Product Code
- LMG FDA UDI
- GMDN Term
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.4490 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
No
FDA UDI
Category: Plant polysaccharide haemostatic agent, bioabsorbable
Ethicon by Ethicon Inc. — Class III — 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
- StopsBleeding™ — Coag Medical, LLC · U
- Benacel Plus — UNICARE BIOMEDICAL, INC. · U
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
- BleedStop™ — Coag Medical, LLC · U
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
Cleared under the same submission
N12159 also covers:
- SURGICEL — Ethicon Inc.
- SURGICEL FIBRILLAR — Ethicon Inc.
- SURGICEL FIBRILLAR — Ethicon Inc.
- SURGICEL FIBRILLAR — Ethicon Inc.
- SURGICEL SNoW — Ethicon Inc.
- SURGICEL SNoW — Ethicon Inc.
- SURGICEL SNoW — Ethicon Inc.
- SURGICEL SNoW — Ethicon Inc.
- SURGICEL SNoW — Ethicon Inc.
- SURGICEL SNoW — Ethicon Inc.
- SURGICEL — Ethicon Sàrl
- SURGICEL — Ethicon Sàrl
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 III | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Inc.
Sources (1)
- FDA UDI 3756b3e0-c6da-4f8a-94a2-5ef48dc5107b 37 fields · synced May 30, 2026