Identity
- Trade Name
- Prontosan® FDA UDI
- Generic Name
- Wound hydrogel dressing, antimicrobial FDA UDI
- Device Name
- Prontosan® Wound Gel X, 250g Tube FDA UDI
- Model / Reference
- 400518 FDA UDI
- Description
- Prontosan® Wound Gel X, 250g Tube FDA UDI
Identifiers
- Catalog Number
- 400518 FDA UDI
- Primary DI / UDI-DI
- 04046964678233 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, 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, antimicrobial
Prontosan® by B. Braun Medical Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, antimicrobial.
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- ProCure — Twin Med, LLC · U
- Armor Gel — Abl Medical, LLC · U
- L-Mesitran Hydro — Theo Manufacturing B.V. · U
- Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC · U
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
- B. Braun Medical Inc.
Sources (1)
- FDA UDI bdd105d9-ad06-4b1b-bae9-39112bfe4c8e 36 fields · synced Jun 1, 2026