Identity
- Trade Name
- UrgoTul Absorb Border FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges. FDA UDI
- Model / Reference
- 550764 FDA UDI
- Description
- A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges. FDA UDI
Identifiers
- Catalog Number
- 550764 FDA UDI
- Primary DI / UDI-DI
- 00190769507640 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial 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
No
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: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
UrgoTul Absorb Border by Urgo Medical North America, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial.
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- Comfeel Plus Transparent — Coloplast A/S · Class I
- DUODERM — CONVATEC, PURCHASING DEPARTMENT · Class I
- Eclypse Adherent — BRIGHTWAKE LIMITED · Class I
- Cutimed® Sorbion® — BSN MEDICAL, INC. · 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
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI e5e71816-7d5a-47e1-9297-4bb3fa5ee254 37 fields · synced Jun 9, 2026