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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
FusionMAX® Heart-Shaped Pad™ FDA UDI
Model / Reference
33501-18-001 FDA UDI
Description
FusionMAX® Heart-Shaped Pad™ FDA UDI

Identifiers

Catalog Number
33501-18-001 FDA UDI
Primary DI / UDI-DI
00840343726737 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization 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 2d2d6277-c674-47e6-8daf-6aff61febb1e 35 fields · synced Jun 8, 2026