Identity
- Trade Name
- TRAUMAGEL ® FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Hemostatic Gel FDA UDI
- Model / Reference
- TG-0001 FDA UDI
- Description
- Hemostatic Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007891144 FDA UDI
- 510(k) Number
- K240713 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial 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
No
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: Wound hydrogel dressing, non-antimicrobial
Traumagel ® by Cresilon, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wound hydrogel dressing, non-antimicrobial.
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- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
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
- Cresilon, Inc.
Sources (1)
- FDA UDI 51a41f09-8700-4fe5-8b0e-fde94f55bc11 35 fields · synced Jun 1, 2026