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QUANTUM™ CT Overlay

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
QUANTUM™ CT Overlay FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Quantum Overlay - Siemens PHS1B FDA UDI
Model / Reference
RT-4550SS4 FDA UDI
Description
Quantum Overlay - Siemens PHS1B FDA UDI

Identifiers

Catalog Number
RT-4550SS4 FDA UDI
Primary DI / UDI-DI
10841962109069 FDA UDI
FDA Product Code
JAI FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5770 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 215 Centimeter FDA UDI

Category: Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA UDI bf287373-ec5f-4846-b1e5-c7046a9f78df 36 fields · synced May 31, 2026