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KeraStat Cream

FDA UDI

Class U (US FDA UDI)

by Keranetics, LLC

Identity

Trade Name
KeraStat Cream FDA UDI
Generic Name
Skin semi-occlusive dressing, non-antimicrobial FDA UDI
Device Name
Non-sterile, non-implantable wound dressing FDA UDI
Model / Reference
00 FDA UDI
Description
Non-sterile, non-implantable wound dressing FDA UDI

Identifiers

Primary DI / UDI-DI
B789P00210 FDA UDI
510(k) Number
K192386 FDA UDI
FDA Product Code
KGN FDA UDI
GMDN Term
Skin semi-occlusive 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

Dimensions & Sizes

Size
Total Volume — 5 Milliliter FDA UDI

Category: Skin semi-occlusive dressing, non-antimicrobial

KeraStat Cream by Keranetics, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin semi-occlusive dressing, non-antimicrobial.

Cleared under the same submission

K192386 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Keranetics, LLC

Sources (1)

  • FDA UDI 8b38b4de-5d09-489f-8aca-e096ff734d8c 37 fields · synced Jun 8, 2026