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Varex Imaging

FDA UDI

Class I (US FDA UDI)

by Varex Imaging Nederland B.V.

Identity

Trade Name
Varex Imaging FDA UDI
Generic Name
X-ray film cassette holder FDA UDI
Device Name
The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-series. FDA UDI
Model / Reference
19388-03 FDA UDI
Description
The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-series. FDA UDI

Identifiers

Primary DI / UDI-DI
08718755001662 FDA UDI
FDA Product Code
IXY FDA UDI
GMDN Term
X-ray film cassette holder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1880 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Varex Imaging by Varex Imaging Nederland B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Varex Imaging Nederland B.V.

Sources (1)

  • FDA UDI ec54f30d-ee6a-4f00-8273-a6fae11e1c68 34 fields · synced Jun 1, 2026