Identity
- Trade Name
- KeraStat Gel FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing FDA UDI
- Model / Reference
- 00 FDA UDI
- Description
- Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing FDA UDI
Identifiers
- Primary DI / UDI-DI
- B789P00100 FDA UDI
- 510(k) Number
- K162759 FDA UDI
- FDA Product Code
- KGN 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
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
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
KeraStat Gel by Keranetics, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
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- 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
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
- Keranetics, LLC
Sources (1)
- FDA UDI ad5386d3-c6b5-4892-8279-27e40c7fad8f 37 fields · synced May 30, 2026