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Allura Xper FD

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Nederland B.V.

Identity

Trade Name
Allura Xper FD FDA UDI
Generic Name
Stationary angiographic x-ray system, digital FDA UDI
Device Name
Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 10-inch flat detector. FDA UDI
Model / Reference
Allura Xper FD10 FDA UDI
Description
Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 10-inch flat detector. FDA UDI

Identifiers

Catalog Number
722026 FDA UDI
Primary DI / UDI-DI
00884838054189 FDA UDI
FDA Product Code
OWB FDA UDI
JAA FDA UDI
GMDN Term
Stationary angiographic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

No

FDA UDI

Category: Stationary angiographic x-ray system, digital

Allura Xper FD by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary angiographic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.

Sources (1)

  • FDA UDI 9ee37c6c-8434-4d25-b898-37dcf2a52d29 34 fields · synced Sep 18, 2026