Identity
- Trade Name
- FOXSEAL Vented FDA UDI
- Generic Name
- Pneumothorax dressing FDA UDI
- Device Name
- Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (English CE/US pack) FDA UDI
- Model / Reference
- FG08814541 FDA UDI
- Description
- Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (English CE/US pack) FDA UDI
Identifiers
- Catalog Number
- FG08814541 FDA UDI
- Primary DI / UDI-DI
- 15060206630694 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Pneumothorax dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumothorax dressing
FOXSEAL Vented by Medtrade Products , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumothorax dressing.
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- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
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- Wound Seal Duo — H & H Medical Corporation · Class I
- Sentinel Chest Seal — SAFEGUARD US OPERATING, LLC · Class I
- MedSource Halo Chest Seal — MEDSOURCE INTERNATIONAL 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtrade Products , Ltd.
Sources (1)
- FDA UDI c69afc0a-2808-4af3-9d25-521a7dcf580f 36 fields · synced May 30, 2026