TRUMATCH - XRAY POSITIONER CUSHION - DEPUY (IRELAND)

Duns Number:989365556

Device Description: XRAY POSITIONER CUSHION

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More Product Details

Catalog Number

200042073

Brand Name

TRUMATCH

Version/Model Number

2000-42-073

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)

-

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

KXH

Product Code Name

Cradle, patient, radiologic

Device Record Status

Public Device Record Key

cac67194-7eaa-4338-9c0c-8d90b49a8393

Public Version Date

May 23, 2019

Public Version Number

4

DI Record Publish Date

January 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY (IRELAND)" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3549
2 A medical device with a moderate to high risk that requires special controls. 2188
3 A medical device with high risk that requires premarket approval 418