Identity
- Trade Name
- Hyalo4 Care Hydrogel, 100g FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Hydrogel wound dressing, 100g Tube FDA UDI
- Model / Reference
- 49444-0100-35 FDA UDI
- Description
- Hydrogel wound dressing, 100g Tube FDA UDI
Identifiers
- Catalog Number
- 49444-0100-35 FDA UDI
- Primary DI / UDI-DI
- M713494440100350 FDA UDI
- 510(k) Number
- K963004 FDA UDI
- FDA Product Code
- MGQ 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
No
FDA UDI
Single Use
No
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
Hyalo4 Care Hydrogel, 100g by Fidia Farmaceutici — 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
- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
- Halo — Medical Devices Inc. · Class I
Cleared under the same submission
K963004 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fidia Farmaceutici
Sources (1)
- FDA UDI d0b0dec8-1703-460f-bd1e-809abbfbf067 37 fields · synced May 30, 2026