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Dermisplus Prevent Heel

FDA UDI

Class I (US FDA UDI)

by Frontier Therapeutics Inc.

Identity

Trade Name
Dermisplus Prevent Heel FDA UDI
Generic Name
Pressure-management bandage, silicone FDA UDI
Device Name
Dermisplus Prevent Heel (pk of 2) FDA UDI
Model / Reference
8500002 FDA UDI
Description
Dermisplus Prevent Heel (pk of 2) FDA UDI

Identifiers

Primary DI / UDI-DI
05056279304122 FDA UDI
FDA Product Code
FMP FDA UDI
GMDN Term
Pressure-management bandage, silicone FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pressure-management bandage, silicone

Dermisplus Prevent Heel by Frontier Therapeutics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure-management bandage, silicone.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Frontier Therapeutics Inc.

Sources (1)

  • FDA UDI 3650be34-936b-4de1-95dc-948c4e7abad6 34 fields · synced May 30, 2026