ProBelt 50 VL - Universal patient positioning belt for MR and CT - Pearl Technology AG

Duns Number:480151859

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

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

1218

Brand Name

ProBelt 50 VL

Version/Model Number

ProBelt 50 VL

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

e9d9306e-3ad2-4c7c-8d10-b0f07cd40fe1

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