FoamFit Wedge 18x11x5 - Universal patient positioning aid for MR and CT - Pearl Technology AG

Duns Number:480151859

Device Description: Universal patient positioning aid for MR and CT imaging.

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More Product Details

Catalog Number

1225

Brand Name

FoamFit Wedge 18x11x5

Version/Model Number

FoamFit Wedge 18x11x5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

KXH

Product Code Name

Cradle, Patient, Radiologic

Device Record Status

Public Device Record Key

de8bc51a-e3c4-44ee-bbf5-81f5bdf4ffcd

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEARL TECHNOLOGY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 126