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FusionMAX

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name
FusionMAX FDA UDI
Generic Name
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
Chest Pad: Memory foam cushion used in conjunction with positioning device to provide comfort and safety to patient in prone position. Specifically designed for use in the chest area FDA UDI
Model / Reference
33501-29-000 FDA UDI
Description
Chest Pad: Memory foam cushion used in conjunction with positioning device to provide comfort and safety to patient in prone position. Specifically designed for use in the chest area FDA UDI

Identifiers

Catalog Number
33501-29-000 FDA UDI
Primary DI / UDI-DI
00840343716622 FDA UDI
FDA Product Code
JEA FDA UDI
GMDN Term
Operating table patient pressure distribution pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Operating table patient pressure distribution pad, reusable

FusionMAX by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgix Medical Llc

Sources (1)

  • FDA UDI 54afb518-03b6-47c7-84bd-e37ee11a8fe4 35 fields · synced May 31, 2026