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RediFoam™

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
RediFoam™ FDA UDI
Generic Name
Patient positioning foam mould kit FDA UDI
Device Name
Two-part Foaming Agent Part A (21.8oz) and Foaming Agent Part B (24.6oz) FDA UDI
Model / Reference
MTFA41B FDA UDI
Description
Two-part Foaming Agent Part A (21.8oz) and Foaming Agent Part B (24.6oz) FDA UDI

Identifiers

Catalog Number
MTFA41B FDA UDI
Primary DI / UDI-DI
00841439110904 FDA UDI
510(k) Number
K951808 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Patient positioning foam mould kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 4.1 Centimeter FDA UDI
Length — 19.4 Centimeter FDA UDI

Category: Patient positioning foam mould kit

RediFoam™ by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning foam mould kit.

Cleared under the same submission

K951808 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI 692025a0-cc3c-4e9f-88ec-750cc618e4f0 38 fields · synced May 29, 2026