Claymount - x-ray beam-limiting device, to restrict the - Varex Imaging Nederland B.V.

Duns Number:413223942

Device Description: x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limi x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator)This is a device out of the Optica 20 series

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More Product Details

Catalog Number

-

Brand Name

Claymount

Version/Model Number

50250-10-USA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IZX

Product Code Name

Collimator, Manual, Radiographic

Device Record Status

Public Device Record Key

318d9af8-66b2-4e1f-9875-c7c06f7cae93

Public Version Date

March 18, 2021

Public Version Number

4

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VAREX IMAGING NEDERLAND B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 164