CT Table Cover 2070 - Universal patient positioning aid for CT imaging. - Pearl Technology AG

Duns Number:480151859

Device Description: Universal patient positioning aid for CT imaging.

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More Product Details

Catalog Number

1168

Brand Name

CT Table Cover 2070

Version/Model Number

CT Table Cover 2070

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

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Device Record Status

Public Device Record Key

d01a7d64-42c8-4361-aa9d-5b242e0320c6

Public Version Date

May 19, 2022

Public Version Number

1

DI Record Publish Date

May 11, 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