Identity
- Trade Name
- Elasto-Gel FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- 4" x 4" Sterile Wound Dressing FDA UDI
- Model / Reference
- DR8000 FDA UDI
- Description
- 4" x 4" Sterile Wound Dressing FDA UDI
Identifiers
- Catalog Number
- 2-025-001 FDA UDI
- Primary DI / UDI-DI
- 00745713580004 FDA UDI
- 510(k) Number
- K872165 FDA UDI
- FDA Product Code
- FRO 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
No
FDA UDI
Over-the-Counter
Yes
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
Elasto-Gel by Southwest Technologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
- Orasoothe Oral Coating Rinse 4oz – Hygiene — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
- Microcyn Skin & Wound HydroGel — Sonoma Pharmaceuticals, Inc. · U
- MYNX CONTROL — Accessclosure, Inc. · Class III
- HydroTac transparent 10x10cm steril P10 — Paul Hartmann Corp. · Class I
- Hyalo4 Care Clear Hydrogel, 100g — Fidia Farmaceutici · U
- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
Cleared under the same submission
K872165 also covers:
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
- Southwest Technologies, Inc.
Sources (1)
- FDA UDI 01926a9d-370f-4e0d-875a-39a681093cbf 37 fields · synced May 30, 2026